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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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Roche’s Chugai Launches Edirol in China for Postmenopausal Osteoporosis
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Swiss pharma giant Roche’s subsidiary Chugai Pharmaceutical Co Ltd has officially launched Edirol (eldecalcitol), an active Vitamin D3 derivative, in China. The drug, approved in December 2020 for treating osteoporosis in postmenopausal women, will be promoted by Chugai Pharma China Co., Ltd and Roche’s local unit. Drug ProfileEdirol, first approved…
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Humanwell Healthcare’s RFUS-144 Wins NMPA Approval for Pruritus Clinical Study
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Category 1 drug RFUS-144 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of pruritus. The drug, a selective opioid agonist, was previously approved for pain relief in China. Drug ProfileRFUS-144 is being…
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Hengrui Medicine Launches Revelutamide for Metastatic Prostate Cancer in China
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Hengrui Medicine has launched revelutamide (SHR3680; trade name: Erion), China’s homegrown innovative androgen receptor (AR) inhibitor, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. The drug received conditional market approval from the National Medical Products Administration (NMPA) in June 2022 and was first prescribed at…
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HutchMed Initiates Phase I Study of CD47 Monoclonal Antibody HMPL-A83 in China
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study for HMPL-A83, its monoclonal antibody (mAb) targeting CD47, in patients with advanced malignant tumors. The first patient was dosed on July 15, 2022. Study DetailsThe multi-center, open-label Phase I trial (NCT05429008) will evaluate the safety,…
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Kexing Pharmaceutical’s SHEN26 COVID-19 Drug Receives NMPA Approval for Clinical Trials
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China-based Kexing Pharmaceutical (SHA: 688136) announced that its oral small-molecule COVID-19 drug SHEN26, co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials. Drug ProfileSHEN26 is a novel coronavirus polymerase (RdRp) inhibitor that blocks viral nucleic acid synthesis.…
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ImmuneOnco’s IMM2902 Receives FDA Fast-Track Designation for CD47/HER2 Targeting
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its bispecific antibody (BsAb)-receptor recombinant protein IMM2902, targeting human CD47 and HER2. The product is the only CD47/HER2 BsAb to enter clinical trials globally. Drug ProfileIMM2902 inhibits tumor cell growth by…
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Pfizer Launches Cejemly in China for Stage III NSCLC, Expands Immunotherapy Reach
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Pfizer announced the commercial launch of Cejemly (sugemalimab) in China for Stage III non-small cell lung cancer (NSCLC), marking the PD-L1 inhibitor’s second approved indication in the country. The therapy, developed by CStone Pharmaceuticals (HKG: 2616) under a license from Ligand Pharmaceuticals (NASDAQ: LGND), is now the only immunotherapy approved…
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Luye Pharma’s Lurbinectedin Receives Hainan Approval for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for lurbinectedin (LY01017), an RNA polymerase II inhibitor, to treat metastatic small-cell lung cancer (SCLC) in patients with disease progression after chemotherapy. The drug will be available through Hainan’s Boao Lecheng International Medical Tourism Pilot Zone,…
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Novartis’ Aimovig Launches in China via GBA Early Access Scheme for Migraine Treatment
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Swiss pharma giant Novartis’ (NYSE: NVS) migraine therapy Aimovig (erenumab) was administered for the first time at Guangzhou United Family Hospital, marking its launch in China through the Greater Bay Area (GBA) early access scheme. The University of Hong Kong-Shenzhen Hospital and Chan Xinghai Hospital have also been approved to…
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CStone Pharmaceuticals’ Gavreto Wins Hong Kong Approval for RET Fusion NSCLC
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CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval in Hong Kong for treating adults with RET fusion-positive metastatic non-small cell lung cancer (NSCLC). The drug, licensed from US-based Blueprint Medicines in June 2018, was approved based on data from the global Phase I/II…
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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…
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Luye Pharma Initiates Phase III Study of Trulicity Biosimilar BA5101 in China
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China-based Luye Pharma Group (HKG: 2186) announced the initiation of a Phase III clinical study in China for BA5101, its biosimilar version of Trulicity (dulaglutide), targeting blood glucose control in adults with type 2 diabetes. Drug ProfileTrulicity, developed by Eli Lilly, is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. It…
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Beijing Science Sun’s LZ901 Shingles Vaccine Receives FDA IND Approval
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China-based Beijing Science Sun Pharmaceutical Co., Ltd (SHE: 300485) announced that its subsidiary Beijing Luzhu Biological Technology Co., Ltd has received IND approval from the US FDA for its recombinant shingles vaccine candidate, LZ901. The approval marks a milestone for China’s first homegrown shingles vaccine to enter global development. Vaccine…
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BeiGene’s Tislelizumab Faces FDA Delay Due to Inspection Hurdles
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision on its Biologics License Application (BLA) for tislelizumab (Baizean), a PD-1 inhibitor, citing the agency’s inability to conduct onsite inspections. The BLA, filed in September 2021, sought approval for second-line treatment of esophageal squamous cell…
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Frontier Biotech and Asymchem Partner on COVID-19 Drug FB2001 Development
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China-based Frontier Biotechnologies Inc. (SHE: 200342) announced a strategic partnership with Asymchem Laboratories (Tianjin) Co., Ltd (SHE: 002821), a Contract Development and Manufacturing Organization (CDMO), to advance the development of FB2001, its COVID-19 3CL protease inhibitor. The collaboration covers R&D, manufacturing, regulatory filing, and production support for pivotal clinical trials.…
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Hangzhou DAC Biotech Doses First Patient in DXC007 AML Study
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing in a Phase I clinical study of its antibody drug conjugate (ADC) DXC007 for relapsed/refractory (r/r) acute myeloid leukemia (AML). The open, multi-center, dosage escalation and expansion trial will assess the drug’s safety, tolerability, and pharmacokinetics. Drug…
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Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
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Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products Administration (NMPA) for reducing chemotherapy-induced myelosuppression (CIM) in adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug, licensed from US biotech G1 Therapeutics, was approved under a prioritized review process. Drug ProfileTrilaciclib, a…
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Huadong Medicine’s Biosimilar Victoza (Liraglutide) Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide), produced by subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, has been accepted by the National Medical Products Administration (NMPA). The drug is intended as an adjunctive therapy for adult…
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Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for efgartigimod, the world’s first FcRn antagonist, targeting generalized myasthenia gravis (MG). Drug ProfileEfgartigimod, developed by Netherlands-based Argenx and licensed to Zai Lab in January 2024 for up…
