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Luye Pharma’s Rotigotine Microspheres Meet Phase III Goals in Parkinson’s Study
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for rotigotine extended-release microspheres for injection (LY03003) in Parkinson’s disease (PD) met all pre-set endpoints. The trial demonstrated the drug’s efficacy and safety in early-stage PD patients. Study DetailsThe multi-center, randomized, double-blind, placebo-controlled study enrolled 294 early…
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Eli Lilly’s Retevmo Wins Special Approval in China’s Lecheng Medical Pilot Zone
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Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor Retevmo (selpercatinib) in China’s Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug will be available at the Boao Super Hospital to treat RET gene fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and…
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Innovent Biologics’ Mazdutide Meets Phase II Goals in Type 2 Diabetes Study
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its Phase II study of mazdutide (IBI362/OXM3) in Chinese patients with type 2 diabetes met primary endpoints. The multi-center, randomized trial compared mazdutide with placebo and dulaglutide in patients with inadequate glucose control despite lifestyle interventions and/or stable metformin doses (NCT04965506). Study…
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Sihuan Pharma’s Fourth-Gen Insulin Degludec NDA Accepted by NMPA for Review
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its New Drug Application (NDA) for a fourth-generation insulin degludec analog has been accepted by the National Medical Products Administration (NMPA) for review. The drug is the first insulin degludec analog to enter the marketing review stage after the originator…
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Sihuan Pharma’s Anaprazole Enters Phase II Study for Reflux Esophagitis
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its subsidiary Xuanzhu Biopharmaceutical Co., Ltd has received approval to proceed with a Phase II clinical study of anaprazole for the treatment of reflux esophagitis (RE) and associated symptoms, including acid reflux, heartburn, and retrosternal pain. Drug ProfileAnaprazole, the only…
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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…
