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AffaMed Technologies’ EDOF Intraocular Lenses Receive FDA Approval in Taiwan
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced that it has received market approvals from the Taiwan Food and Drug Administration for its MINI WELL, MINI WELL PROXA, and MINI WELL TORIC intraocular lenses, as well as the monofocal intraocular lens MINI 4 Ready. These…
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Walvax Biotechnology Announces Positive Results for RQ3013 mRNA Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the safety, immunogenicity, and protective efficacy results of a Phase IIIb clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The vaccine was co-developed by Shanghai Llanque Biomedical Co., Ltd and…
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AIM Vaccine Initiates Phase I Clinical Study for MCV4 Meningococcal Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the initiation of a single-center, open Phase I clinical study for its ACYW135 meningococcal polysaccharide conjugate vaccine, MCV4. The study is expected to enroll 120 subjects, marking a significant step in the development of this vaccine. Market Context and CompetitionCurrently, commercially…
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Bochuang Biotechnology Secures Angel Funding for High-Purity Collagen and Innovative Medical Product Development
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Jiangsu Bochuang Biotechnology Co., Ltd reportedly secured an undisclosed amount of funding in an angel financing round led exclusively by Dalton Venture. The proceeds will be utilized for the extraction of high-purity active collagen, the in-depth development of oral bone tissue-guided membrane adhesive and artificial cornea, and the establishment of…
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NMPA Accepts Market Filing for Guangdong Zhongsheng’s COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that the market filing for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step towards the potential commercialization of the drug for COVID-19…
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Mabwell Bioscience’s 9MW3811 Gains NMPA Approval for Clinical Trials in China
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb). The drug is intended for the treatment of various advanced malignant tumors and fibrotic diseases. It…
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Everest Medicines’ Xerava Receives NMPA Approval for Complicated Intra-Abdominal Infections
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China-based Everest Medicines Limited (HKG: 1952) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in China, with plans to commercialize the product during the…
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Terumo Blood and Cell Technologies Partners with EurekaBio to Establish Cell Therapy Lab
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US-based Terumo Blood and Cell Technologies has entered into a partnership with Shenzhen-headquartered EurekaBio Technology to jointly establish a cell therapy process development platform laboratory. The collaboration aims to advance innovations in cell therapy, although no financial details were disclosed. About Terumo Blood and Cell TechnologiesTerumo Blood and Cell Technologies…
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Fosun Pharma’s Generic Remodulin Gains NMPA Approval for Pulmonary Arterial Hypertension
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its generic version of Remodulin (treprostinil) has been approved by the National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH). The drug is marketed to alleviate symptoms caused by exercise. Understanding PAH and…
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RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
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China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase I/IIa study. The study will assess the safety, tolerability, pharmacokinetics, and efficacy of RC88 combined with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab),…
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Triastek Partners with Boehringer Ingelheim to Advance 3D Printed Drug Dosage Forms
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China-based Triastek Inc., a leading pharmaceutical-focused 3D printing company, has entered into a partnership with German pharmaceutical giant Boehringer Ingelheim. The collaboration aims to explore the application of 3D printing in the development of new chemical entity (NCE) drug dosage forms, although no financial details were disclosed. Triastek’s Technology and…
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ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment…
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ArkBio and Calibr Renew Collaboration to Develop First-in-Class Respiratory Drug AK0705
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Shanghai Ark Biopharmaceutical Co., Ltd announced that it has renewed its co-development collaboration with Calibr, a division of Scripps Research, to develop AK0705, a potential first-in-class drug targeting an enzyme that plays a crucial role in respiratory inflammation. The drug is intended to treat a broad spectrum of respiratory diseases,…
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Agena Bioscience’s CYP2C19 Genotyping Kit Gains NMPA Approval for Cardiovascular Applications
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Shanghai-based Agena Bioscience announced that its human CYP2C19 genotyping test kit, co-developed with Simcere Pharmaceutical Group’s subsidiary Simcere Diagnostics, has been approved by the National Medical Products Administration (NMPA) as a Category III product. The kit is designed for the qualitative detection of CYP2C19 gene polymorphism in peripheral blood samples…
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Ping An Life Insurance Reports Steady Profit Growth and Expands Managed Care Services
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Ping An Life Insurance Company of China Ltd released its 2022 financial report, recording RMB 148.365 billion (USD 21.485 billion) in operating profits, up 0.3% year-on-year (YOY). The company also reported RMB 107.432 billion (USD 15.55 billion) in net profits and RMB 83.774 billion (USD 12.13 billion) in net profits…
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Akeso Biopharma Reports 422% Increase in Product Sales, Boosted by Cadonilimab and Penpulimab
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China-based Akeso Biopharma (HKG: 9926) released its 2022 financial report, highlighting significant growth in product sales. The company reported RMB 1.104 billion (USD 159.97 million) in product sales, representing a 422% year-on-year (YOY) increase. Product Sales and Market ApprovalsThe innovative bispecific antibody cadonilimab (AK104), targeting programmed death-1 (PD-1) and cytotoxic…
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CStone Pharmaceuticals Reports 97.54% Revenue Growth in 2022, Driven by Drug Sales and Licensing Fees
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China-based CStone Pharmaceuticals (HKG: 2616) released its 2022 financial report, recording total revenues of RMB 481.4 million (USD 69.78 million), marking a 97.54% year-on-year (YOY) increase. This growth was primarily driven by drug sales and licensing fees for Cejemly (sugemalimab). Commercial revenues reached RMB 394.1 million (USD 57.1 million), up…
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Henlius’ OX40 Monoclonal Antibody HLX51 Gains NMPA Approval for Phase I Clinical Study
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in mainland China for its OX40 monoclonal antibody (mAb), HLX51. The study will focus on patients with advanced/metastatic solid tumors and lymphoma. Mechanism…
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Boao Lecheng and Shanghai Biomed Center Form Long-Term Partnership for Medical Innovation
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The Boao Lecheng Medical Tourism Pilot Zone of Hainan Province has entered into a long-term partnership with the Shanghai Center of Biomedicine Development. The collaboration will focus on various areas, including human genetic resources project management, international exchange and cooperation, translation of scientific and technological achievements, and enterprise innovation incubation…
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Haisco Pharmaceutical’s EGFR-PROTAC HSK40118 Gains NMPA Approval for Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral small molecule EGFR-PROTAC, HSK40118. The drug is targeted for the treatment of advanced non-small cell lung cancer (NSCLC). Drug Mechanism and Pre-Clinical ResultsHSK40118…
