-
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
-
LaNova Medicines Inks Licensing Deal with Sino Biopharmaceutical for Cancer Therapies in China
•
Shanghai-based LaNova Medicines Ltd, a developer of cancer therapies, has announced another licensing deal, signing an agreement with compatriot firm Sino Biopharmaceutical Ltd (HKG: 1177) for the development and commercialization of LM-108 and other potential bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs) in mainland China. The specifics of the…
-
AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
•
US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
-
VelaVigo and Avenzo Therapeutics Ink Global Partnership for Nectin4/TROP2 Bispecific ADC
•
Shanghai-based biotech company VelaVigo, specializing in bispecific/multi-specific antibodies and antibody drug conjugates (ADCs), has announced a global strategic partnership with US oncology firm Avenzo Therapeutics, Inc. This collaboration will facilitate the global development, manufacturing, and commercialization of VelaVigo’s Nectin4/TROP2 bispecific ADC, excluding Greater China, where VelaVigo retains the rights. Details…
-
Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
-
C-Ray Therapeutics Secures Over $100 Million in Series A+ Financing for Radiopharmaceuticals
•
C-Ray Therapeutics, a specialist in radiopharmaceuticals headquartered in Chengdu, has announced the successful completion of a Series A+ financing round, raising over USD 100 million. The funding was co-led by Shenzhen Capital Group’s Manufacturing Transformation and Upgrading New Materials Fund and Tailong Capital, with additional contributions from GL Ventures, 3SBio…
-
BlissBio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
•
BlissBio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors, signifying…
-
GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
•
UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
-
Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
•
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
-
Biocytogen’s First-in-Class B7H3/PTK7 Bispecific ADC Option Exercised by IDEAYA Biosciences
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315), a China-based biopharmaceutical company, has announced that its US partner IDEAYA Biosciences Inc. (NASDAQ: IDYA) has exercised its option for an exclusive worldwide license for Biocytogen’s IDE034. This potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) represents a significant step forward in…
-
Alteogen Secures Exclusive Licensing Deal with Daiichi Sankyo for Subcutaneous Enhertu
•
Alteogen Inc. (KOSDAQ: 196170), a South Korea-based biotechnology company, has announced an exclusive licensing agreement with Japan-headquartered Daiichi Sankyo (TYO: 4568). This strategic partnership grants Daiichi Sankyo worldwide rights to utilize Alteogen’s ALT-B4, a novel hyaluronidase based on Hybrozyme Technology, in the development and commercialization of a subcutaneous version of…
-
Alphamab Oncology Presents JSKN033 Phase I/II Study Results at SITC 2024
•
Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
-
Sichuan Biokin Pharmaceutical Gets FDA Approval for Phase I Study of BL-M17D1 in Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-M17D1, in patients with advanced solid tumors. BL-M17D1’s…
-
CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
•
The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
-
Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
-
Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
-
Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
•
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
-
LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
•
LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
-
Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
•
Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
-
Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
-
LaNova Medicines Secures RMB 300 Million in Series C1 Financing to Advance Cancer Therapy Pipeline
•
LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the successful completion of a Series C1 financing round, raising RMB 300 million (USD 42.1 million). The funding round was led by Sino Biopharmaceutical Ltd (HKG: 1177), with significant contributions from Shanghai Pudong Venture Capital, Zhangjiang Haoheng Innovative Equity…
-
Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation…
-
RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
•
AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
-
Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
•
Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
-
Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or…
-
HitGen Inc. Partners with Ablink Biotech to Develop Antibody-Oligonucleotide Conjugates
•
China-based HitGen Inc. (SHA: 688222) has entered into a partnership with compatriot firm Ablink Biotech to integrate their world-leading trillion-level DNA-Encoded Libraries (DELs), a comprehensive small nucleic acid drug discovery and production platform, and a 300 billion-level biopharmaceutical molecule library. The collaboration aims to provide research and development services for…
-
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
-
CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
-
MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
•
Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
-
Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
•
Duality Biotherapeutics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
-
BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
•
On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
-
FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
•
Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
-
NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
•
The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
-
Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
-
Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
-
AbbVie Submits First BLA for c-Met Targeting ADC Telisotuzumab Vedotin to FDA
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
-
Elevation Oncology’s Claudin 18.2 Targeting ADC Earns FDA Fast Track Designation for Gastric Cancer
•
Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
-
CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
•
The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
-
Sichuan Kelun-Biotech Reports 32.2% Revenue Growth in 2024 H1, Driven by MSD Partnership
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
-
GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
•
The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
-
Alphamab Oncology’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies
•
Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid…
-
Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
•
Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
-
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
-
Duality Biotherapeutics Initiates Global Clinical Trial for DB-1419 in Advanced Solid Tumors
•
Duality Biotherapeutics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
-
AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
•
AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
-
Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
-
European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
•
Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
-
GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
•
SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
-
China’s Sinovent and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
•
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential…
-
Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
-
Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
•
Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
-
Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
•
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is…
-
China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
•
The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
-
Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
-
Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
-
Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
•
Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
-
Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
•
LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
-
Genmab CEO Signals Potential for China Partnership as BioNTech Exits acasunlimab Collaboration
•
COPENHAGEN—In a strategic pivot following BioNTech (NASDAQ: BNTX)’s withdrawal from their co-development partnership on the PD-L1 x 4-1BB bispecific antibody acasunlimab, Denmark-based Genmab A/S (NASDAQ: GMAB) is reportedly seeking a commercial partner for its entry into the China market. This update was provided by CEO Jan Van de Winkel during…
-
Sichuan Kelun Pharmaceutical’s H1 2024 Report Highlights MSD Collaboration Milestones
•
CHENGDU—Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has released its financial report for the first half of 2024, detailing significant updates on its collaboration with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK). The partnership, focused on the co-development of antibody drug conjugates (ADCs), has seen substantial progress…
-
Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
•
TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
-
BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
•
FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
-
Multitude Therapeutics and Adcendo ApS Partner on Anti-TF ADC, Targeting Global Cancer Treatment
•
SHANGHAI/COPENHAGEN—In a strategic move to bolster cancer treatment options, Shanghai-based medical technology company Multitude Therapeutics Inc. has entered into a licensing agreement with Denmark’s Adcendo ApS, a specialist in antibody drug conjugates (ADCs). The deal grants Adcendo exclusive global rights to develop and commercialize an anti-human tissue factor (TF) ADC,…
-
Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
-
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
•
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
-
Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
•
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
-
Mabwell’s Nectin-4 Targeting ADC 9MW2821 on Path to Breakthrough Designation in China for Urothelial Carcinoma
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the…
-
Daiichi Sankyo Reports 24.3% YOY Revenue Growth, Driven by Enhertu and Lixiana
•
Daiichi Sankyo (TYO: 4568), a leading pharmaceutical company in Japan, reported a significant year-on-year (YOY) growth of 24.3%, with revenues reaching JPY 436.18 billion (USD 3.0 billion). This Q1’24 result is notable for being the first to not include revenues from Daiichi Sankyo Espha, the company’s generics unit that was…
-
Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
-
Biocytogen Strikes Licensing Deal with IDEAYA for Potential First-in-Class BsADC Program
•
China-based Biocytogen (HKG: 2315) has entered into an option and licensing agreement with US-based IDEAYA Biosciences Inc. (NASDAQ: IDYA) for the development of Biocytogen’s B7H3/PTK7 program, a potential first-in-class bispecific antibody drug conjugate (BsADC). The agreement grants IDEAYA the option for an exclusive worldwide license to the drug, which has…
-
NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
•
The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
-
Pfizer Inc. Reports Q2 2024 Earnings with First Positive Growth Since Q4 2022 Peak
•
Pfizer Inc. (NYSE: PFE), a leading US pharmaceutical company, has announced its financial results for the second quarter of 2024, showing a 3% year-on-year (YOY) increase in global revenues in constant currency terms, reaching USD 13.283 billion. This marks the first quarter of positive growth for Pfizer since the peak…
-
Jiangsu Hengrui Medicine Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
-
Shanghai Escugen Partners with Innolake Biopharma to Develop Novel ADCs Using EZWi-Fit Platfo
•
Shanghai Escugen, a Chinese biopharmaceutical company, has entered into a strategic partnership with fellow Chinese firm Innolake Biopharma to utilize Escugen’s innovative antibody-drug conjugate (ADC) platform, EZWi-Fit, in the development of ADC products targeting specific antigens selected by Innolake. Under the terms of the agreement, Innolake will employ EZWi-Fit to…
-
Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
•
Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
-
AstraZeneca’s Q2 2024 Results Highlight Strong Growth Across Therapies, Excluding Vaccines
•
AstraZeneca (NASDAQ: AZN), a UK-based biopharmaceutical company, has reported its financial results for the second quarter and the first half of 2024, demonstrating robust growth. For the six-month period, total revenues increased by 18% year-on-year (YOY) to $25.617 billion, with product sales also experiencing an 18% rise to $24.629 billion.…
-
Shanghai Medicilon and Jiangsu Hengrui Join Forces to Advance Pre-Clinical Drug Evaluation
•
Shanghai Medicilon Biomedical Co., Ltd, a leading biopharmaceutical company based in China, has entered into a strategic partnership with Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent player in the global pharmaceutical industry. This collaboration aims to leverage Medicilon’s pre-clinical research and development expertise with Hengrui’s innovative drive and…
-
Shanghai Escugen and Sidewinder Therapeutics Form Strategic Alliance for ADC Development
•
Shanghai Escugen, a leading biopharmaceutical company specializing in antibody drug conjugates (ADCs), has announced a strategic partnership with US-based Sidewinder Therapeutics Inc. Under the agreement, Sidewinder has been granted a license to Escugen’s proprietary EZWi-Fit ADC platform, enabling the development of multiple ADC products. This collaboration signifies a significant step…
-
Mabwell Bioscience Lands Orphan Drug Status for B7-H3 Targeting ADC in Small Cell Lung Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), 7MW3711. The drug targets B7-H3, a receptor overexpressed in various cancers, and is specifically indicated for the treatment of small cell lung cancer…
-
Biocytogen Strikes Exclusive Deal with SOTIO Biotech for Next-Gen ADCs
•
Biocytogen (HKG: 2315), a leading biopharmaceutical company based in China, has announced a strategic research collaboration and licensing agreement with the Netherlands-based SOTIO Biotech B.V. The partnership grants SOTIO an exclusive option to license multiple fully human bispecific antibodies generated through Biocytogen’s proprietary RenLite platform. These antibodies will be utilized…
-
Full-Life Technologies Strikes USD 571.5 Million Licensing Deal with SK Biopharmaceuticals for Radiopharmaceutical Asset
•
Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has entered into a lucrative licensing agreement with South Korea-based SK Biopharmaceuticals, granting the latter exclusive global rights to develop, manufacture, and commercialize the radiopharmaceutical FL-091. The deal is valued at USD 571.5 million…
-
BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
-
Mabwell Bioscience’s 9MW2821 Earns FDA Fast Track Designation for Triple Negative Breast Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development…
-
Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
•
Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
-
Ipsen Strikes Global Licensing Deal with Foreseen Biotechnology for First-in-Class ADC FS001
•
Ipsen (EPA: IPN; OTCMKTS: IPSEY), a French biopharmaceutical company, has announced a global licensing agreement with Chinese startup Foreseen Biotechnology for the latter’s lead pipeline candidate, FS001. This agreement grants Ipsen exclusive rights to develop, manufacture, and commercialize the antibody-drug conjugate (ADC) on a global scale. As per the terms…
-
Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
-
Biokin Pharmaceutical Co., Ltd Eyes Secondary Listing on HKEX, Co-Sponsored by Goldman Sachs and Others
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a company listed on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR) since October 2022, is reportedly planning a secondary listing on the Hong Kong Stock Exchange (HKEX). The firm’s IPO is being co-sponsored by prominent investment banks Goldman Sachs, J.P. Morgan, and…
-
Quantum Hi-Tech Partners with East China Normal University to Establish Advanced Drug Research Lab
•
Quantum Hi-Tech (China) Biotechnology Co., Ltd, known as ChemPartner (SHE: 300149), has entered into a strategic partnership with Shanghai’s East China Normal University (ECNU). The collaboration aims to establish a state-of-the-art joint laboratory dedicated to advancing research in drug discovery, biochips, drug delivery systems, and drug conjugates (XDCs). Furthermore, the…
-
CSPC Pharmaceutical’s SYS6023 Receives FDA Approval for Clinical Study in Advanced Solid Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
-
Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
-
Full-Life Technologies’ ²²⁵Ac-FL-020 Earns FDA Fast-Track Status for mCRPC
•
Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its investigational drug ²²⁵Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA-targeted radionuclide…
-
Bristol-Myers Squibb Ends Collaboration with Eisai on Farletuzumab Eteribulin
•
Bristol-Myers Squibb (BMS; NYSE: BMY), a prominent US pharmaceutical company, has decided to terminate its collaboration with Japanese pharmaceutical firm Eisai Co., Ltd, which was focused on the co-development of Eisai’s antibody drug conjugate (ADC) farletuzumab ecteribulin (FZEC; MORAb-202). According to a press release from Eisai, BMS’s decision is part…
-
Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
-
Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
•
Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
-
Shanghai’s Phrontline Biopharma Secures Over RMB 100 Million in Pre-Series A Funding for ADC Development
•
Shanghai-based antibody drug conjugate (ADC) specialist Phrontline Biopharma has reportedly secured over RMB 100 million (USD 13.8 million) in a pre-Series A financing round, with funds exclusively provided by Decheng Capital. The capital raised will be directed towards bolstering research and development efforts, pre-clinical development, and the enhancement of its…
-
Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
•
Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
-
Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
-
Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
•
Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase…
-
Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
-
BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
•
BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
-
RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
-
Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
-
AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
-
Alphamab Oncology Partners with ArriVent BioPharma for Global ADC Development and Commercialization
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a research and development (R&D) and commercialization cooperation agreement with ArriVent BioPharma, Inc. (NASDAQ: AVBP), a U.S. biopharmaceutical firm. The collaboration aims to jointly discover, develop, and commercialize innovative antibody-drug conjugates (ADCs) for oncology treatments. According to…
-
Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
-
Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
•
Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
-
Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
•
Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
-
Full-Life Technologies Receives FDA Green Light for ²²⁵Ac-FL-020 Clinical Study in mCRPC
•
Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its investigational drug ²²⁵Ac-FL-020 in patients with metastatic castration-resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA (prostate-specific…
-
Medilink Therapeutics Partners with BioNTech to Develop ADC Products Using TMALIN Technology
•
Medilink Therapeutics, based in Suzhou, has entered into another partnership agreement with German biotechnology company BioNTech SE (NASDAQ: BNTC). This collaboration allows BioNTech to utilize Medilink’s TMALIN ADC technology platform for the development of specific antibody drug conjugate (ADC) products. According to the terms of the deal, BioNTech will make…
-
Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
-
Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
•
The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
-
RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
-
AstraZeneca Sets Sights on $80 Billion Revenue Target and 20 New Molecular Entities by 2030
•
At its recent investor day, AstraZeneca plc (NASDAQ: AZN), a prominent UK pharmaceutical company, articulated its long-term objectives to shareholders. The company outlined an ambitious plan to achieve revenues of $80 billion by 2030, which is nearly double the $45.8 billion reported in 2023. This target will be pursued by…
-
Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
-
Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
-
AstraZeneca Commits $1.5 Billion to Build Singapore-Based ADC Manufacturing Facility
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced plans for a $1.5 billion greenfield investment to establish a manufacturing presence in Singapore with the construction of a state-of-the-art antibody-drug conjugate (ADC) production site. This facility will be the company’s first end-to-end manufacturing hub, handling all stages of ADC production,…
-
Genmab CEO Cites China’s Biotech as a ‘Mind-Boggling’ Source of Innovation
•
Jan van de Winkel, CEO of Denmark-based biotech Genmab (NASDAQ: GMAB), has expressed optimism about the potential of China’s biotech industry to drive innovation for multinational corporations (MNCs). This sentiment comes in the wake of Genmab’s significant foray into the Chinese market with the acquisition of Sino-US antibody-drug conjugate (ADC)…
-
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
-
Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-B16D1, in patients with advanced solid tumors. Biokin Pharma,…
-
Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
•
Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
-
Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
-
Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
-
Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
-
Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
-
Daiichi Sankyo Reports 25.3% Revenue Growth in FY2023, Boosted by Enhertu and Lixiana Sales
•
Japanese pharmaceutical company Daiichi Sankyo has reported a remarkable fiscal year 2023, with revenues increasing by 25.3% to ¥1.602 trillion (USD 10.05 billion) for the 12-month period ended March 31, 2024. The growth was primarily driven by the success of its HER2-targeted antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) and…
-
Roche’s Q1 2024 Turnover Rises 2% YOY, Driven by New Medicines and Diagnostics
•
Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has reported a 2% year-on-year (YOY) increase in turnover at constant exchange rates (CER) for the first quarter of 2024, reaching CHF 14.4 billion (USD 15.7 billion). The growth was modest but steady, driven by newer medicines and diagnostics, which compensated for…
-
Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
-
Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
-
Shanghai Escugen and Anke Bio Partner to Develop ADC Products with EZWi-Fit Platform
•
Shanghai Escugen, a biopharmaceutical company based in China, has entered into a licensing and cooperation agreement with Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009). Under the terms of the agreement, Escugen will grant Anke Bio the rights to its antibody-drug conjugate (ADC) technology platform, EZWi-Fit, for the development of…
-
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
-
Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
•
The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
-
Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
-
Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
•
The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
-
Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
•
Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
-
Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
•
Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
-
Merck Sharp & Dohme Acquires Abceutics for Next-Generation ADC Technology
•
Global healthcare leader Merck, Sharp & Dohme (MSD) (NYSE: MRK) has secured a strategic acquisition of Abceutics, a preclinical biopharmaceutical startup focused on optimizing antibody-drug conjugates (ADCs). The financial details of the transaction remain undisclosed. Abceutics has developed a series of payload-binding selectivity enhancers (PBSEs) designed to increase the safety…
-
Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
-
Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
-
Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
•
Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
-
BeiGene Launches Guangzhou ADC Production Park to Strengthen Manufacturing Muscle
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has announced the operational launch of its antibody drug conjugate (ADC) production park in Guangzhou, a strategic move to bolster the company’s clinical and commercial manufacturing capabilities. The new facility is expected to significantly enhance the production of BeiGene’s…
-
Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
-
Merck Collaborates with Caris Life Sciences to Develop First-in-Class Antibody-Drug Conjugates
•
German pharmaceutical giant Merck (ETR: MRK) has entered into a strategic collaboration with Caris Life Sciences’ research unit, Caris Discovery, to uncover novel oncology targets and develop first-in-class antibody-drug conjugates (ADCs). The partnership aims to harness Caris’ precision medicine expertise and Merck’s ADC technology to accelerate the discovery and development…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
•
Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
-
Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
-
Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
-
Genmab Acquires Profound Bio for $1.8 Billion, Targeting Expanding ADC Pipeline
•
Denmark-based biotech Genmab A/S (NASDAQ: GMAB) has announced a significant all-cash acquisition of Sino-US biotech Profound Bio, targeting its antibody drug conjugate (ADC) pipeline in a deal valued at $1.8 billion, set to close in the first half of 2024. The agreement has received approval from the boards of both…
-
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
•
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
-
Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
-
Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
-
Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
•
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
-
Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
-
FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
•
This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
-
Biocytogen and ABL Bio Forge Partnership to Advance Bispecific ADC Development
•
China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has entered into a partnership with South Korea’s ABL Bio Inc. (KOSDAQ: 298380) to advance the development of bispecific antibody drug conjugates (ADCs). ABL Bio is a research-driven biotechnology firm recognized for its pioneering work in bispecific antibodies aimed at treating immuno-oncology…
-
Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
•
Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
-
Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
•
Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
-
CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
-
WuXi XDC Breaks Ground on State-of-the-Art Manufacturing Base in Singapore to Boost ADC Production
•
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced plans to construct a new manufacturing base at the Tuas Biomedical Park in Singapore. This strategic expansion is designed to enhance the joint venture’s…
-
Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
•
The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for…
-
Hansoh Pharmaceutical Secures Global Rights to Biotheus’ BsAb HS-20117/PM1080
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has announced a licensing agreement with domestic firm Biotheus. Under the terms of the agreement, Hansoh will secure exclusive global rights to develop, manufacture, and commercialize Biotheus’s bispecific antibody (BsAb) HS-20117/PM1080, along with sub-license rights. The…
-
Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
-
Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
-
Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
-
Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
•
Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
-
Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
-
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
•
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
-
Sichuan Biokin and Bristol-Myers Squibb Activate $800 Million ADC Licensing Deal
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has officially activated its licensing and cooperation agreement with U.S. pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) for the development of Biokin’s BL-B01D1 antibody-drug conjugate (ADC) candidate, effective February 8, 2024. As of March 7, the company confirmed receipt of the USD 800…
-
Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
•
The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
-
Apeloa Pharmaceutical and ZhenGe Biotech Join Forces to Create Comprehensive ADC Platform
•
China-based Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has entered into a strategic partnership with domestic Contract Development and Manufacturing Organization (CDMO) ZhenGe Biotech. The collaboration aims to establish an antibody drug conjugate (ADC) platform that offers a range of diversified antibodies, highly active small molecule payloads, and linker technology. The…
-
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
•
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
-
Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
•
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
-
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
•
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
-
Harbour BioMed Partners with Boostimmune to Develop Novel ADC Therapies
•
Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced an antibody drug conjugate (ADC) discovery cooperation agreement with South Korea-based ADC specialist Boostimmune, Inc. The financial details of the agreement have not been disclosed. As per the terms…
-
Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
-
Mabwell Bioscience’s Nectin-4 Targeting ADC Earns FDA Fast-Track Designation for Esophageal Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
-
Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
-
Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
-
BMS and Sichuan Biokin Commence Joint Development of EGFR/HER3-Targeted ADC
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced that a licensing and cooperation agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has officially come into effect as of February 8, 2024, following the expiration of the waiting period for the deal. The agreement…
-
China’s CDE Issues Guiding Principles for ADC Research and Evaluation
•
China’s Center for Drug Evaluation (CDE) has issued a notification outlining the “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates (ADCs).” The document aims to standardize and guide the research, development, and regulatory submissions pertaining to ADCs. The guidelines are applicable to ADC products that are created…
-
Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
•
Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
-
Gilead’s 2023 Stagnation Foresees Flat 2024 Sales as Veklury Revenues Dwindle
•
Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
-
Shanghai Procurement Platform Offers Price Cut Leeway to Escape ‘High-Priced Drugs’ Tag
•
Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) platform has announced a significant policy shift regarding non-winning bids in the 9th round of volume-based procurement (VBP). The notification suggests that drugs which did not secure a winning bid and are eligible for online procurement in Shanghai may be exempted from the “high-priced…
-
BioNTech and Duality’s DB-1305 Earns Fast-Track Status for Platinum-Resistant Cancers
•
German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…
-
Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
•
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
-
MindRank Ltd Partners with Henlius Biotech to Pioneer AI-Powered Drug Therapies
•
MindRank Ltd, a China-based frontier in AI-enabled drug development, has inked a strategic partnership with Shanghai Henlius Biotech Inc. (HKG: 2696), a fellow Chinese firm, to co-develop AI-driven antibody drug conjugate (ADC) and anti-aging therapy platforms. This alliance combines Henlius’s comprehensive biopharmaceutical platform, specialized in antibody and Linker Payload technologies,…
-
WuXi XDC Partners with Multitude Therapeutics and Signs MOU with Shanghai Huilian to Advance ADC Technologies
•
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has entered into a strategic partnership with Shanghai-based antibody drug conjugate (ADC) specialist, Multitude Therapeutics. Additionally, WuXi XDC has signed a memorandum of understanding (MOU) with…
-
Mabwell Bioscience Extends Research Partnership with Fudan University Cancer Center
•
Mabwell (Shanghai) Bioscience Co., Ltd., (SHA: 688062) has announced the renewal of its strategic research partnership with Fudan University Shanghai Cancer Center. The collaboration, initiated in July 2021, focuses on advancing research cooperation, nurturing talent, enhancing hospital management, and constructing robust platforms for scientific exchange. The partnership has seen significant…
-
AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
-
Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
•
Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which…
-
Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
•
German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
-
WuXi XDC Partners with Celltrion to Support Global Development and Manufacturing of Bioconjugated Drugs
•
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a cooperation memorandum of understanding (MOU) with South Korean firm Celltrion Inc. (KRX: 068270) to provide comprehensive services for the development and manufacturing of…
-
Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
•
Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
-
USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
•
In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
-
RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
•
RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
-
RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
•
China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. Developed in-house,…
-
BioNTech Acquires Pre-Clinical Asset and ADC Technology from Portuguese Biotech CellmAbs
•
Germany’s BioNTech (NASDAQ: BNTX) has licensed a pre-clinical antibody candidate and additional antibody-drug conjugate (ADC) technology from Portugal-based biotechnology company CellmAbs. The agreement marks Portugal’s first billion-dollar transaction in the life sciences sector. Under the terms, CellmAbs will receive undisclosed upfront and near-term payments, potential milestone payments reaching several hundred…
-
Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
•
The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
-
OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
•
OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2. The antibody molecules utilized in the development of…
-
Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
•
Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to acquire Ambrx Biopharma (NASDAQ: AMAM), a U.S.-based developer of antibody drug conjugates (ADCs). The deal is valued at approximately USD 2 billion in equity and carries a net cash requirement of USD 1.9 billion, with…
-
Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
•
The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
-
Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
-
Biocytogen Strikes Exclusive Licensing Deal with US-Based Radiance Biopharma for Innovative BsADC
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a leading biopharmaceutical company based in China , has announced the signing of an Exclusive Option and License Agreement with Radiance Biopharma Inc., a specialist in antibody drug conjugates (ADCs) headquartered in Boston, U.S. The agreement provides Radiance with the option to license…
-
MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
-
OnCusp Therapeutics Secures Oversubscribed USD 100 Million Series A Financing for CDH6-Targeting ADC
•
OnCusp Therapeutics, a U.S.-based biopharmaceutical company, has closed an oversubscribed Series A financing round, raising USD 100 million. The round was led by Novo Holdings, OrbiMed, and F-Prime Capital, with significant contributions from BioTrack Capital, a Chinese investor involved in OnCusp’s seed funding, Catalio Capital Management, Marshall Wace, Forge Life…
-
WuXi XDC and IntoCell Enter MOU to Advance Toxin Linker Technology and CRDMO Services
•
WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has recently announced a memorandum of understanding (MOU) with South Korea-based IntoCell. The collaboration aims to comprehensively work on new toxin linker technology and contract research,…
-
Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
•
Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
-
Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
•
China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate (ADC) BA1301 have received orphan drug designations (ODDs) from the U.S. Food and Drug Administration (FDA). Both therapies target Claudin18.2 (CLDN18.2) for the treatment of pancreatic cancer. BA1105 is being developed for Claudin18.2 positive advanced…
-
Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth…
-
Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
•
Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced…
-
Innovent Biologics Partners with Xuanzhu Biopharma for Clinical Trial of Sintilimab and KM-501 in Advanced Tumors
•
Innovent Biologics, Inc. (HKG: 1801), based in China, has entered into a clinical trial collaboration and supply agreement with Xuanzhu Biopharma to explore the combination therapy of Tyvyt (sintilimab) with KM-501, a novel HER-2 bispecific antibody drug conjugate (ADC). This partnership aims to develop potential treatment options for advanced solid…
-
J&J’s Janssen Secures Exclusive Global Rights to Develop LCB84 ADC from LegoChem Biosciences
•
Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical subsidiary, Janssen, has entered into an exclusive global agreement with South Korean-based LegoChem Biosciences (LCB; KOSDAQ: 141080) to develop and commercialize the antibody drug conjugate (ADC) LCB84. Under the terms of the agreement, LCB is set to receive $100 million in upfront payments…
-
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
•
The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
-
Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
•
Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
-
GSK Secures Exclusive Rights to Hansoh’s ADC Candidate HS-20093 in New Licensing Deal
•
GlaxoSmithKline (GSK; NYSE: GSK), a major UK pharmaceutical company, has entered into its second licensing agreement with Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) within two months, focusing once again on an antibody-drug conjugate (ADC) product candidate. Hansoh has granted GSK exclusive rights to develop, manufacture, and commercialize its novel…
-
Shanghai Escugen Partners with InxMed for Global Development Rights to EZWi-Fit Platform
•
Shanghai Escugen has entered into a partnership with InxMed (Nanjing) Co., Ltd, granting the Chinese firm non-exclusive global rights to Escugen’s EZWi-Fit linker-payload platform for the development of next-generation tumor-associated antigen (TAA)-targeting antibody drug conjugates (ADCs). Under the terms of the license agreement, InxMed is authorized to utilize the EZWi-Fit…
-
RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
•
China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) RC88, which targets mesothelin (MSLN) in gynecological tumors. This approval paves the way for global multi-center Phase II clinical trials to…
-
Biocytogen and Ona Therapeutics Forge Antibody Evaluation and Licensing Agreement
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315), based in China, has entered into an antibody evaluation, option, and licensing agreement with Spain’s Ona Therapeutics. According to the terms of the agreement, Biocytogen will provide Ona with access to evaluate its proprietary RenMice-derived fully human antibodies targeting a specific tumor. Ona…
-
Seagen Inc. Acquires Global Rights to HBM9033 ADC in Deal with Nona Biosciences and Medilink Therapeutics
•
Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), and Suzhou-based Medilink Therapeutics have jointly announced the licensing of their co-developed antibody-drug conjugate (ADC), HBM9033 (YL215), to Pfizer Inc.’s (NYSE: PFE) unit Seagen Inc. (NASDAQ: SGEN). According to the agreement, Seagen will secure global clinical development and commercialization rights…
-
Lepu Biotechnology’s Pancreatic Cancer Drug Earns Orphan Drug Status from FDA
•
Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
-
Sichuan Biokin and Bristol Myers Squibb Ink USD 8.4 Billion Licensing Deal for ADC Candidate
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced a landmark licensing and cooperation agreement with US pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY). The agreement focuses on Biokin’s antibody-drug conjugate (ADC) candidate, BL-B01D1, which targets EGFR and HER3. The deal was conducted specifically between…
-
Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
•
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
-
Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
•
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
-
Innovent Biologics Expands Partnership with Synaffix for New ADC Development
•
Innovent Biologics Inc. (HKG: 1801) has announced an expanded partnership with U.S.-based Synaffix B.V., a subsidiary of Lonza (SWX: LONN). This follows an initial agreement from June 2021, during which Innovent successfully utilized Synaffix’s antibody-drug conjugate (ADC) technology platforms on a non-exclusive basis to develop IBI343, an anti-CLDN18.2 ADC that…
-
AbbVie to Acquire ImmunoGen for USD 10.1 Billion, Expanding Oncology Portfolio
•
AbbVie (NYSE: ABBV) has reached an agreement to acquire fellow U.S. biotech ImmunoGen (NASDAQ: IMGN) for an equity value of approximately USD 10.1 billion. The transaction is anticipated to close in mid-2025, pending the fulfillment of customary regulatory conditions. This acquisition will enhance AbbVie’s portfolio with Elahere (mirvetuximab soravtansine), an…
-
Lepu Biotechnology’s MRG003 Gains Fast-Track Status from U.S. FDA for Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug…
-
Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
•
Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
-
AbbVie’s Telisotuzumab-Vedotin Shows Promising Results in NSCLC Phase 2 Trial
•
AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
-
Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
-
BMS and Avidity Biosciences Join Forces on $2.2 Billion Cardiology Antibody Oligonucleotide Conjugate Deal
•
Bristol Myers Squibb (BMS, NYSE: BMY) has announced a strategic partnership with Avidity Biosciences (NASDAQ: RNA) focused on the discovery, development, and commercialization of cardiology-oriented antibody oligonucleotide conjugates (AOCs). This innovative class of RNA therapeutics merges the specificity of monoclonal antibodies with the precision of oligonucleotide therapies, building on insights…
-
Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
-
Shanghai Escugen Partners with Foreseen Biotechnology for ADC Development
•
China-based Shanghai Escugen has entered into a partnership with domestic firm Foreseen Biotechnology to develop antibody drug conjugates (ADCs) leveraging Escugen’s linker-payload technology, EZWi Fit, and Foreseen’s first-in-class antibodies and targets. This collaboration aims to create ADCs with enhanced drug efficacy and resistance in various tumor models, offering differentiated clinical…
-
Medilink Therapeutics’ YL201 Earns Orphan Drug Designation for Esophageal Cancer
•
Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) YL201, which is being developed to treat esophageal cancer (EC). YL201, a B7H3-targeted ADC product, is based on Medilink’s Tumor Microenviroment Activable LINker (TMALIN)…
-
WuXi Biologics’ Subsidiary WuXi XDC Lists on Hong Kong Stock Exchange
•
WuXi Biologics (HKG: 2269) has successfully spun off its conjugate drug-focused subsidiary, WuXi XDC Cayman Inc., (HKG: 2268) to the Hong Kong Stock Exchange on Friday, November 17, 2023. Through the global offer, WuXi XDC issued 178.44 million shares at a price of HK 20.60 per share. The gross proceeds…
-
Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
•
Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
-
Nona Biosciences Partners with GeneQuantum Healthcare to Advance Drug Conjugate Discovery
•
Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), which operates across the Netherlands, the United States, and China, has entered into a partnership with China-based GeneQuantum Healthcare. The collaboration aims to integrate the core technology platforms and professional expertise of both companies to empower the early discovery…
-
BMS Secures ORM-6151 for Acute Myeloid Leukemia Treatment with Orum Therapeutics Deal
•
Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…
-
Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
•
Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report that the licensing agreement with China’s BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) for the antibody drug conjugate (ADC) zanidatamab zovodotin (ZW49) has been cancelled. This development affects the HER2-targeted ADC that BeiGene had…
-
FibroGen Inc. Reports 155% YOY Sales Increase in Q3 2023 Financial Results
•
US-based biotechnology company FibroGen Inc., (NASDAQ: FGEN) has reported its financial results for the third quarter of 2023, showcasing a significant year-on-year (YOY) increase in global sales. The company’s revenues rose by 155% to USD 40.1 million, reflecting the success of its anti-anemia drug for chronic kidney disease (CKD), Evrenzo…
-
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
•
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
-
BioNTech Secures Exclusive Rights to Biotheus Inc.’s BsAb PM8002 in Landmark Deal
•
Germany’s BioNTech (NASDAQ: BNTX) has entered into an exclusive license and collaboration agreement with China-based Biotheus Inc., focusing on the development and commercialization of the bispecific antibody (BsAb) PM8002. The deal grants BioNTech development, manufacturing, and commercial rights to PM8002 in all markets outside of Greater China, marking a significant…
-
Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
•
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
-
Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
•
IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
-
Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
•
US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
-
Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
•
Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for the six months ended September 30, 2023, reaching JPY 726.3 billion (USD 4.8 billion), according to the company’s financial report published this week. This growth was driven by a combination of factors, including the depreciation…
-
Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
-
Merck KGaA and Jiangsu Hengrui Ink Strategic Collaboration Deal for Next-Gen PARP1 Inhibitor
•
Germany-based Merck KGaA (NYSE: MRK) has announced the signing of a strategic collaboration deal with China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276). This agreement grants Merck development, manufacturing, and commercial rights to the next-generation PARP1 inhibitor HRS-1167 for all global territories outside of China. Additionally, Merck has an option…
-
Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
-
Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
-
EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
•
The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
-
MSD Cancels Development of Two Pre-Clinical ADCs from Sichuan Kelun-Biotech
•
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) have announced that their US partner Merck, Sharp & Dohme (MSD; NYSE: MRK) has decided to cancel the development of one pre-clinical antibody drug conjugate (ADC) and will not…
-
Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
•
China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in…
-
Hansoh Pharmaceutical and GSK Ink Global Licensing Deal for Innovative ADC HS-20089
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has entered into a licensing agreement with UK pharmaceutical giant GSK (NYSE: GSK), granting GSK development, manufacturing, and commercialization rights to its pipeline antibody drug conjugate (ADC) HS-20089 for all global territories outside Greater China. HS-20089: Targeting B7-H4 in OncologyHS-20089 is an…
-
MSD Collaborates with Daiichi Sankyo on Development of Innovative ADC Candidates
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based Daiichi Sankyo (TYO: 4568) focused on the development and commercialization of three potential first-in-class deruxtecan-based antibody-drug conjugate (ADC) candidates. This partnership aims to advance innovative treatments for various types of cancer. ADC Candidates and Development…
-
WuXi XDC Partners with Hong Kong Science Park to Boost CRDMO Value Chain
•
WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has entered into a strategic cooperation framework agreement with Hong Kong Science and Technology Parks Corp. The partnership aims to promote the establishment of a Contract Research, Development,…
-
Eli Lilly Acquires Mablink Bioscience to Expand Next-Gen ADC Portfolio
•
US pharmaceutical company Eli Lilly (NYSE: LLY) has signed an agreement to acquire France-based Mablink Bioscience, a biotechnology firm specializing in next-generation antibody-drug conjugates (ADCs). This strategic move is set to enhance Eli Lilly’s capabilities in developing innovative oncology treatments through Mablink’s advanced ADC technology. Mablink’s Proprietary ADC TechnologyMablink Bioscience’s…
-
Merck KGaA Partners with Porton Pharma for Next-Gen ADC Platform Development
•
German pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a strategic partnership with China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions’ Shanghai unit. The collaboration aims to develop a next-generation integrated antibody drug conjugate (ADC) platform technology, marking a significant step in the advancement of oncology treatments.…
-
Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
-
Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
•
China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
-
RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
•
China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
-
Medilink Therapeutics Enters Global Licensing Agreement with BioNTech for HER3-Targeted Antibody Drug Conjugates
•
Suzhou-based Medilink Therapeutics has announced a strategic cooperation and global licensing agreement with Germany-headquartered BioNTech SE (NASDAQ: BNTX). Under this partnership, the two companies will collaborate to develop next-generation antibody drug conjugates (ADCs) targeting the human epidermal growth factor receptor 3 (HER3). Leveraging TMALIN Technology for Enhanced Efficacy The ADC…
-
Eli Lilly Launches Three New Oncology Programs Targeting KRAS and Nectin-4
•
Eli Lilly (NYSE: LLY) has announced the initiation of three innovative oncology programs focusing on KRAS and Nectin-4, all of which are currently in the pre-clinical stage. This strategic move highlights Lilly’s commitment to advancing cancer therapies that target specific oncogenic pathways. Details of the New Oncology Programs The new…
-
ZhenGe Biotech Partners with Glyco-Therapy to Develop Antibody Drug Conjugate Platform
•
China-based Contract Development and Manufacturing Organization (CDMO) ZhenGe Biotech has announced a strategic partnership with domestic firm Glyco-Therapy. This collaboration aims to create a comprehensive resource cooperation and service platform for the development of next-generation antibody drug conjugates (ADCs). Innovative Approach to ADC Development The partnership will focus on the…
-
Hangzhou HealSun Biopharm Secures RMB 200 Million in Series B+ Financing
•
Hangzhou HealSun Biopharm Co., Ltd., a Chinese contract research organization (CRO) and contract development and manufacturing organization (CDMO) specializing in antibodies and recombinant proteins, has successfully raised nearly RMB 200 million (approximately USD 27.8 million) in a Series B+ financing round. The funding was led by China Medical System Holdings…
-
RemeGen and Akeso Biopharma Initiate Phase II Study for Gastric Cancer Combo Therapy
•
China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…
-
Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
-
Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
•
The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
-
Jiangsu Hengrui Medicine Secures NMPA Approvals for Two Cancer Drug Candidates
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
-
Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
-
MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
•
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
-
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
-
AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
•
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
-
AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
•
AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
-
Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
•
Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
