-
Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
•
The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
-
AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
•
AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
-
Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
-
BioCity Biopharma Partners with AstraZeneca for Phase Ib/II Study in Hepatocellular Carcinoma
•
China-based biotech firm BioCity Biopharma has entered into a clinical study partnership with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The collaboration aims to conduct a Phase Ib/II study assessing the safety and efficacy of BioCity’s BC3402 in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of advanced hepatocellular cell…
-
Shanghai Shende Wuchuang Secures $28 Million in Series D Financing for Medical Device Innovation
•
Shanghai Shende Wuchuang Times Medical Technology Co., Ltd has reportedly secured nearly RMB 200 million (USD 28 million) in a Series D financing round, bringing the company’s total funding to RMB 400 million (USD 56 million). The investors in this round include Zhuji Huiri Yingtian Equity Investment and Hefei Industrial…
-
GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
•
GluBio Pharmaceutical Co., Ltd, a specialist in molecular glue targeted protein degradation (TPD) based in Zhejiang, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its molecular glue degrading agent, GLB-002. The drug is indicated for the treatment of non-Hodgkin’s lymphoma (NHL)…
-
BMS to Acquire Mirati Therapeutics in a $4.8 Billion Deal
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a definitive merger agreement with US-based oncology specialist Mirati Therapeutics (NASDAQ: MRTX) in a transaction valued at USD 4.8 billion, with an additional potential contingent value right (CVR) payment of up to USD 1.0 billion to Mirati stockholders. The companies anticipate completing…
-
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…
-
Beijing Launches Comprehensive Plan to Eliminate Cervical Cancer by 2030
•
The Beijing Municipal Health Commission, in collaboration with the Beijing Municipal Medical Insurance Bureau and seven other governmental bodies, has unveiled an “Implementation Plan for Accelerating the Elimination of Cervical Cancer in Beijing (2023-2030).” This ambitious campaign aims to significantly reduce cervical cancer incidence through a series of targeted preventive…
-
Mabwell Bioscience Enters Licensing Agreement with Laboratorios Legrand for Biosimilars in Colombia and Ecuador
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced a strategic licensing agreement with Colombia-headquartered Laboratorios Legrand S.A. Under this agreement, Laboratorios Legrand will manage the regulatory filing and commercialization of Mabwell’s biosimilars, MAILISHU and 9MW0321, which are both biosimilars of denosumab. This deal specifically covers the territories of…
-
HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
•
China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
-
Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
•
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 clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
-
Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
•
Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
-
Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
•
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
-
Eli Lilly Acquires Point Biopharma to Enhance Oncology Portfolio
•
Eli Lilly (NYSE: LLY) announced last week its agreement to acquire radiopharmaceutical company Point Biopharma (NASDAQ: PNT) in a strategic move to bolster its oncology portfolio with several pre-clinical and clinical radioligand candidates. The acquisition, valued at USD 1.4 billion, will involve Lilly purchasing all outstanding shares of Point through…
-
Takeda Initiates Global Withdrawal of Exkivity Following Phase III Trial Results
•
Japan-based Takeda (TYO: 4502) has announced the voluntary global withdrawal of its tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib) from the U.S. market. This decision comes after a Phase III confirmatory trial failed to meet its primary efficacy endpoint. Exkivity, a first-in-class therapy, had previously received conditional approvals worldwide as a…
-
PharmaEssentia Announces Licensing Agreement with WuXi Biologics for Antibody Development
•
Taiwan-based PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1) has entered into a licensing agreement with China’s WuXi Biologics (HKG: 2269), a leading Contract Research, Development, and Manufacturing Organization (CRDMO). This agreement grants PharmaEssentia exclusive rights for research and development, manufacturing, and marketing of specific antibody sequences targeting the myeloid immune checkpoint,…
-
Vela Diagnostics Partners with SRL Inc. to Expand Molecular Diagnostics in Japan
•
Singapore-based Vela Diagnostics, a global leader in integrated molecular solutions for diagnosing infectious diseases and cancer, has announced a strategic research collaboration with SRL Inc., a premier Japanese healthcare service provider. This partnership is designed to enhance the distribution of Vela Diagnostics’ advanced molecular diagnostic solutions within Japan, although financial…
-
Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
•
China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and…
-
CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
•
CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
