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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…
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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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Shanghai Ark Bio Raises Series D Funding to Advance Pediatric and Respiratory Drug Pipeline
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China-based Shanghai Ark Biopharmaceutical Co., Ltd has completed a Series D financing round, following its Series C round in January 2021. The latest round was led by Loyal Valley Capital and included participation from C&D Emerging Industry Equity Investment, Longda Foods, and existing investors such as Oriza Holdings, Qiming Venture…
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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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China’s 2021 Healthcare Report Shows Rising Life Expectancy, Increased Medical Spending
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China’s National Health Commission (NHC) released the “Healthcare Statistical Communique 2021,” revealing increased healthcare spending, improved life expectancy, and enhanced pandemic response capabilities. The report highlights key metrics in medical resources, services, and public health. Key Health Indicators Medical Resources Medical Services Patient Expenditure COVID-19 Response
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Sinopharm Biotec and Ganzhou Government Partner on Medical Testing and Biotech R&D
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Sinopharm China National Biotec Group Co., Ltd (CNBG) announced a strategic partnership with the government of Ganzhou, Jiangxi Province, to collaborate on medical testing, research and development of innovative pet drugs, and the production of blood products. Partnership DetailsThe agreement will see CNBG and Ganzhou work together in multiple biomedical…
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Basecare Medical and Haier Biomedical Partner on IVF Cryopreservation Tech
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China-based IVF specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) announced a strategic partnership with compatriot firm Haier Biomedical Co., Ltd to collaborate on research and development in assisted reproductive cryogenic preservation. Financial terms of the agreement were not disclosed. Partnership FocusThe partnership aims to advance technologies in cryopreservation for…
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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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CorrectSequence Therapeutics’ tBE Tech Wins USPTO Patent for Gene Editing
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Shanghai-based gene editing firm CorrectSequence Therapeutics announced it has received a patent from the United States Patent and Trademark Office (USPTO) for its variant base editing (tBE) system, a technology designed to enhance precision and reduce off-target mutations in gene editing. Technology HighlightsThe tBE system integrates a deoxycytidine deaminase inhibitor…
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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…
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Overland ADCT BioPharma Doses First Patient in Zynlonta’s Phase III LOTIS-5 Study for DLBCL
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Overland ADCT BioPharma (CY) Ltd, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the first patient dosing in the Phase III confirmatory LOTIS-5 study of Zynlonta (loncastuximab tesirine) for diffuse large B-cell lymphoma (DLBCL). The trial will evaluate the drug’s efficacy and safety…
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Triastek Partners with Eli Lilly to Explore 3D Printing for GI Drug Delivery
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China-based Triastek Inc., a pharmaceutical 3D printing specialist, announced a partnership with US firm Eli Lilly & Co. (NYSE: LLY) to explore 3D printing technology for precise, programmed drug release in the gastrointestinal (GI) tract. Partnership GoalsThe collaboration will focus on two key areas: Triastek’s Technology PlatformTriastek utilizes its MED…
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Zhejiang Medicine’s ARX305 ADC Receives Clinical Trial Approval for CD70-Positive Cancers
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) announced that its subsidiary NovoCodex Biopharmaceuticals Ltd has received approval to conduct a clinical study of ARX305, a Category 1 biologic drug targeting CD70 and AS269, for advanced tumors. The drug is designed to treat CD70-positive cancers, including renal cell carcinoma and multiple…
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GenScript ProBio Partners with ACT Therapeutics on CAR-T Cell Therapy Development
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GenScript ProBio, a global Contract Development and Manufacturing Organization (CDMO), announced a memorandum of understanding (MOU) with South Korea’s ACT Therapeutics to collaborate on cell therapy development. GenScript will act as ACT’s global partner, providing plasmid and virus vector services to advance ACT’s chimeric antigen receptor (CAR) T cell therapy…
