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Skyline Therapeutics’ Gene Therapy SKG0201 for SMA Gets Green Light from China’s NMPA
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Skyline Therapeutics has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its proprietary AAV gene therapy, SKG0201 injection, which is being developed as a treatment for type I spinal muscular atrophy (SMA). SKG0201 is an SMN1 gene replacement therapy that is administered through a single intravenous…
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Sichuan Biokin and Bristol Myers Squibb Ink USD 8.4 Billion Licensing Deal for ADC Candidate
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced a landmark licensing and cooperation agreement with US pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY). The agreement focuses on Biokin’s antibody-drug conjugate (ADC) candidate, BL-B01D1, which targets EGFR and HER3. The deal was conducted specifically between…
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Kangtai Biological Partners with Gennvax Egypt to Commercialize 13-Valent Pneumococcal Vaccine
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a Chinese biopharmaceutical company, has entered into an agency and technology transfer agreement with Egyptian firm Gennvax Egypt concerning Kangtai’s 13-valent pneumococcal polysaccharide conjugate vaccine. Under the terms of the agreement, the two companies will collaborate to advance the marketing approval of…
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Haplox and Illumina Mark Milestone with Production of NextSeq 2000Dx-CN-HAP Sequencing System in China
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Haplox Biotechnology Co., Ltd, a Chinese biotech firm, and US industry leader Illumina (NASDAQ: ILMN) have jointly announced the production line completion of the first NextSeq 2000Dx-CN-HAP gene sequencing system, a domestically produced product manufactured in Shenzhen. The collaboration will now concentrate on local manufacturing of high-end life sciences equipment…
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CDE Requests Feedback on 77th Batch of Chemical Generic Reference Preparations by December 20
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The Center for Drug Evaluation (CDE) is currently soliciting feedback on the 77th batch of chemical generic reference preparations, with a deadline set for December 20, 2023. This batch includes 26 new specifications and 57 additional specifications. However, 18 specifications did not pass the review process, primarily due to issues…
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Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
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Nona Biosciences Partners with Evive Biotech to Discover H2L2 Antibodies Using Harbour Mice Platform
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a research partnership with Evive Biotech Ltd, a subsidiary of Chinese pharmaceutical company Yifan Pharmaceutical Co., Ltd (SHE: 002019). The collaboration will utilize Nona’s antibody technology platform, Harbour Mice, to focus on the discovery of dual…
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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
