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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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VBP Round 7 Drug Procurement Contract Awards Top Winners Revealed
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China’s 7th national Volume-Based Procurement (VBP) round concluded with winning bids for 60 drug products worth over RMB4.4 billion ($651 million). The results, released by VBP authorities, show Shijiazhuang No. 4 Pharmaceutical Co. Ltd as the top contract winner, while six foreign firms secured deals totaling RMB76.7 million (1.7% of…
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Merck KGaA Launches Uptune Program in Asia, Offers Startups Up to €100,000
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Germany-based life sciences giant Merck KGaA has launched the Uptune program in Asia, offering up to €100,000 ($101,000) to startups in healthcare, life science, electronics, and smart manufacturing. The initiative aims to identify early-stage companies and support proof-of-concept studies, pilot projects, and partnerships with Merck. Program DetailsUptune is open to…
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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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Sihuan Pharma to Sell Generic Drug Businesses, Shift Focus to Aesthetics and Biologics
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced plans to divest a portion of its generic drug and “non-core” conventional medicine businesses. The move follows a strategic review aimed at refocusing resources on higher-growth sectors. Strategic RationaleThe board intends to offload products not aligned with performance expectations or long-term…
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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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NMPA Approves RocketHeart’s LV Assist System and Our United Group’s Radiation Therapy Device
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The National Medical Products Administration (NMPA) has approved marketing for two innovative medical devices: RocketHeart’s implantable left ventricular assist system and Our United Group’s gamma beam stereotactic radiation therapy system. Both products feature proprietary technologies and mark firsts in China’s medical device landscape. RocketHeart’s LV Assist SystemRocketHeart’s device provides mechanical…
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Ping An Good Doctor Partners with China Biotech Services for Cancer Testing and BNCT Treatment
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China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as PingAn Good Doctor, announced a strategic partnership with compatriot firm China Biotech Services Holdings Ltd. The collaboration aims to integrate medical services, innovation, and technology to enhance offerings in health testing, medical assistance, and advanced cancer therapies.…
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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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Shanghai Electric and Siemens Partner on Localization of High-End Medical Equipment
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China’s Shanghai Electric Group has partnered with Germany-based Siemens Healthineers to localize high-end medical equipment, aiming to advance innovation and improve access to quality medical resources in China. Financial terms of the agreement were not disclosed. Collaboration DetailsThe partnership will focus on innovating Chinese medical equipment, promoting quality medical resources…
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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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Ningbo HicRen Biotech Completes RMB100M Pre-Series C Financing for Orthopedic Robots
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Ningbo HicRen Biotechnology Co., Ltd, a China-based robotics-driven minimally invasive orthopedics platform, announced the completion of a pre-Series C financing round of RMB100 million ($14.8 million). The round was led by Haichuang Group and Ningbo Qianwan Holding Group, with proceeds allocated to R&D, regulatory filings, and commercialization of orthopedic surgical…
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CStone Pharmaceuticals Explores Strategic Options Including Buyout
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China-based CStone Pharmaceuticals (HKG: 2616) is evaluating strategic options, including a potential buyout, according to Bloomberg. The firm has enlisted Goldman Sachs to explore market interest, with sources indicating openness to a full takeover or sale of a controlling stake. This follows I-Mab’s reported exploration of suitors in April, marking…
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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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Acotec Scientific’s AcoArt Orchid & Dhalia DCB Wins China Approval for AVF PTA
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that its AcoArt Orchid & Dhalia DCB, a drug-coated balloon (DCB) product, has received indication expansion approval in China for use in autologous arteriovenous fistula (AVF) percutaneous transluminal angioplasty (PTA) in hemodialysis patients. The approval marks the product as the first of…
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Orion Holdings to Build Jining Vaccine Plant in China’s Shandong Province
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South Korea-based conglomerate Orion Holdings Corp. will enter China’s vaccine market by constructing a manufacturing plant in Jining city, Shandong Province. The company signed an agreement with local authorities this week to build a 49,600-square-meter biotechnology complex, with an investment of KRW90 billion ($69 million), set to begin operations by…
