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CDE Issues Guidelines for Anti-Tumor ADC Clinical Development
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Anti-Tumor Antibody Drug Conjugates” and is seeking public feedback for one month. The document aims to provide a framework for the rational design of clinical trials involving antibody drug conjugates (ADCs) for anti-tumor…
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Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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Kelun Pharmaceutical Receives USD 35 Million from Merck Sharp & Dohme Corp.
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that it has received a USD 35 million payment from US-based Merck Sharp & Dohme Corp. (MSD), in accordance with the licensing agreement signed in July this year. Under the agreement, MSD has obtained global development, manufacturing, and commercial rights to…
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Northeast Pharma Licenses MedAbome’s MAb11-22.1 for ADC and CAR-T Development
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China’s Northeast Pharmaceutical Co., Ltd (SHE: 000597) has signed a licensing agreement with U.S.-based MedAbome to develop the latter’s preclinical monoclonal antibody, MAb11-22.1, for antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies. The deal follows Northeast’s 2017 in-licensing of a Herceptin biosimilar from MedAbome. Collaboration TermsUnder the agreement,…
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Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
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China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ. Drug…
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RemeGen’s H1 2022 Revenue Soars 1,094% on Aidixi, Taiai Sales
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China-based biotech RemeGen (HKG: 9995) reported RMB 349 million (USD 50.5 million) in revenue for H1 2022, a 1,094.8% year-on-year surge, driven by sales of its two marketed products: Aidixi (disitamab vedotin), a HER2-targeted ADC for cancer, and Taiai (telitacicept), a fusion protein for autoimmune diseases. Product Approvals and Trials…
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Bio-Thera Solutions Receives NMPA Approval for BAT8008 Clinical Trial in Solid Tumors
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials. Drug ProfileBAT8008 combines a recombinant…
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Daiichi Sankyo’s Enhertu Accepted for Review in China for HER2-Low Breast Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced that its market approval filing for Enhertu (T-DXd, trastuzumab deruxtecan), a HER2 antibody drug conjugate (ADC), has been accepted for review by the Center for Drug Evaluation (CDE) in China. The filing seeks approval for the treatment of adult patients with unresectable or…
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Gilead Transfers Trodelvy Asian Rights to Everest Medicines for USD280m
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US pharmaceutical major Gilead Sciences Inc. (NASDAQ: GILD) today announced an agreement with Everest Medicines (HKG: 1952) to transfer the development and commercialization rights for Trodelvy (sacituzumab govitecan) in Asian territories. Trodelvy is a TROP-2 targeted antibody drug conjugate (ADC). The deal regains control of the drug’s Asian rights for…
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Innovent Biologics and Sanofi Announce License Deal for Drug Development in China
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China-based biotech firm Innovent Biologics Inc. (HKG: 1801) and France’s Sanofi SA (NASDAQ: SNY) have announced a license and collaboration agreement. Under the deal, Sanofi will license two of its drugs to Innovent for development in China, alongside Innovent’s PD-1 inhibitor Tyvyt (sintilimab). Sanofi will also invest EUR300 million (USD306…
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ProfoundBio Receives FDA Approval for PRO1184, Appoints New CMO
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China-based macromolecular targeted therapy developer ProfoundBio (Suzhou) Co., Ltd announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) PRO1184 in advanced tumors. The announcement was made alongside the appointment of Dr. Naomi Hunder as the company’s chief…
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AstraZeneca’s H1 2022 Revenues Surge 48%, Led by Oncology and Vaccines
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UK-based AstraZeneca (AZ, NASDAQ: AZN) released its financial report for H1 2022, showing a 48% year-on-year (YOY) increase in total global revenues to USD22.16 billion in constant currency terms. The company saw strong growth across various disease areas and key products. Business Performance Key Products COVID-19 Portfolio Geographical Performance Challenges…
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Mabwell Bioscience Gets FDA Approval for Nectin-4 ADC 9MW2821 in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials…
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LaNova Medicines Gets FDA Green Light for LM-305 Myeloma Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I/II study of LM-305, an antibody drug conjugate (ADC) targeting GPRC5D, in patients with multiple myeloma (MM). Drug ProfileLM-305 is the first GPRC5D-targeting ADC…
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Merck’s Q2 Sales Surge 31% to USD 14.6B, Led by Keytruda and China Growth
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US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) reported Q2 2022 global sales of USD 14.6 billion, marking a 31% increase in constant exchange rate (CER) terms. The growth was driven by recovery from COVID-19 disruptions and contributions from the COVID-19 antiviral drug Lagevrio (molnupiravir). Key Growth Drivers China PerformanceChina…
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CSPC Jushi Biopharm’s SYSA1801 ADC Secures Licensing Deal with Elevation Oncology
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd, has entered into a licensing agreement with US-based Elevation Oncology Inc. (NASDAQ: ELEV). The deal grants Elevation exclusive development and commercialization rights to CSPC Jushi’s Claudin 18.2 (CLDN18.2) antibody drug conjugate (ADC) candidate SYSA1801…
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Sichuan Kelun Pharmaceutical and Merck Sharp & Dohme Corp. Ink Second ADC Licensing Deal
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that US-based Merck Sharp & Dohme Corp. (MSD) has entered into a second licensing agreement, securing global development, manufacturing, and commercialization rights to an undisclosed investigational antibody drug conjugate (ADC) from Kelun’s pipeline. The deal includes an upfront payment of USD…
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DAC Biotech’s DXC005 ADC Doses First Patient in Beijing Cancer Hospital Trial
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing of its antibody drug conjugate (ADC) DXC005 in a clinical study at Beijing Cancer Hospital’s gastrointestinal oncology department. The trial marks progress in DAC Bio’s pipeline of oncology-focused ADC candidates. Drug ProfileDXC005 combines a MUC-1 targeting antibody…
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Sesen Bio Terminates Vicineum Development After FDA Talks, Citing Phase III Costs
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Sesen Bio Inc. (NASDAQ: SESN) announced the termination of clinical development for Vicineum (VB4-845), its next-generation antibody drug conjugate (ADC) for non-muscle invasive bladder cancer, following discussions with the U.S. FDA. The decision cited costs associated with conducting another Phase III study. Drug Profile and Licensing DealVicineum, developed on Sesen…
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Kelun Pharma’s SKB264 ADC Receives NMPA Green Light for Phase II Solid Tumor Study
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study in advanced solid tumors. The trial will assess SKB264 in…
