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Hybio Pharmaceutical’s Semaglutide API Receives FDA Review Acceptance
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug Administration (FDA) has accepted for review the market filing for its semaglutide active pharmaceutical ingredients (APIs). This development marks a significant step for the company as it seeks to enter the global market with its…
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YSB Inc. Lists on HKSE with HKD 363.6 Million IPO, Targeting Digital Pharma Services
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China-based ex-hospital digital pharmaceutical service platform YSB Inc. (HKG: 9885) has successfully made its initial public offering (IPO) on the Hong Kong Stock Exchange (HKSE). The company issued 15,808,800 shares, priced at HKD23 per share, resulting in a total capital raise of HKD 363.6 million. Shanghai Fosun Pharmaceutical Group Co.,…
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Mabwell Bioscience’s IL-11 mAb 9MW3811 Receives US FDA Clinical Trial Approval
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF). Therapeutic…
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Hansoh Pharmaceutical Gets NMPA Approval for HIF-2α Inhibitor HS-10516 Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment…
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Sino Biopharmaceutical Secures Exclusive Rights to Gmax Biopharm’s GMA106 in Greater China
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Sino Biopharmaceutical Ltd (HKG: 1177) through its subsidiary Chia Tai Tianqing Pharmaceutical Co., Ltd, has entered into a licensing agreement with Gmax Biopharm, securing exclusive development and commercialization rights in Greater China for Gmax’s GMA106. The agreement involves Sino Bio paying Gmax Bio a combined USD 57 million in upfront…
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UIH Surgical to Invest RMB 2.5 Billion in Wuhan Medical Innovation and Robotics Base
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United Imaging Healthcare Technology Co., Ltd (UIH), through its subsidiary UIH Surgical, has announced plans to invest RMB 2.5 billion (USD 349.2 million) in the establishment of a medical innovation base in Wuhan Optics Valley. The project will also include the development of an intelligent production base for medical robots,…
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JJET’s IPO on STAR Market Accepted, Aims to Raise RMB 2.691 Billion for Medical Device Expansion
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China-based JJET has received acceptance for its Initial Public Offering (IPO) filing on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The offering is anticipated to raise RMB 2.691 billion (USD 375.9 million), with the proceeds earmarked for the construction of the company’s medical device research and development and technology…
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Genevector Initiates Clinical Study for JWK001 in Neovascular Age-Related Macular Degeneration
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Chengdu-based adeno-associated virus (AAV) gene therapy developer, Genevector Biotechnology Co., Ltd., has announced the first patient dosing in a clinical study for its product candidate, JWK001. The molecule is under assessment as a potential treatment for neovascular age-related macular degeneration (nAMD). JWK001’s Mechanism of Action and Preclinical PerformanceJWK001 employs AAV…
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Convalife Pharmaceuticals Gets NMPA Approval for Generic Neratinib Clinical Study
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Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
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Croma-Pharma Initiates Phase III Clinical Trial in China for Hyaluronic Acid Dermal Filler
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Austria-based Croma-Pharma has revealed that the first patient is set to be enrolled in a clinical trial in China to support the approval of its hyaluronic acid dermal filler, Princess Volume Lidocaine. This randomized, multi-center, blinded, parallel Phase III study will confirm the safety and efficacy of Croma’s product, focusing…
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Mass General Brigham Partners with Simcere Pharmaceutical for Cancer and Autoimmune Disease Research
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Top-tier US medical institution Mass General Brigham Incorporated (MGB) has signed a sponsored research agreement with Chinese firm Simcere Pharmaceutical Group (HKG: 2096). The collaboration will see up to eight research groups at MGB receive funding for select projects over a two-year period, with a focus on developing new treatment…
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Apeloa Pharmaceutical Partners with Zelgen Biopharmaceuticals for CDMO Programs
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China-based contract development and manufacturing organization (CDMO) Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced a strategic partnership agreement with Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266). The collaboration is set to focus on long-term CDMO programs, with specific financial details not disclosed in the announcement. Collaboration on CDMO ProgramsThe…
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Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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Bio-Thera Solutions’ BAT6026 Receives NMPA Approval for Atopic Dermatitis Clinical Trials
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The Role of OX40 in Immune Response and BAT6026’s MechanismOX40, an immune checkpoint expressed…
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Dizal Pharmaceutical’s Sunvozertinib Gets EU Approval for Global Phase III Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for…
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CSPC Pharmaceutical Gets NMPA Approval for ATM Inhibitor SYH2051 Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its in-house developed Category 1 chemical drug, SYH2051. The molecule is set to be assessed in the treatment of general solid tumors. ATM…
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VIVA Biotech Holdings Divests Stake in Shanghai Unit to Temasek-Backed Entities
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China-based Contract Research Organization (CRO) VIVA Biotech Holdings (HKG: 1873) has agreed to sell a stake in its Shanghai unit to entities backed by Singapore’s investment fund Temasek and China-based HighLight Capital, raising RMB 1.06 billion (USD 148.7 million). This transaction reduces VIVA Biotech’s stake in VIVA Shanghai from 100%…
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China Medical System’s Diazepam Nasal Spray Receives NMPA Approval for Cluster Seizures
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China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a…
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Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ICML
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its JAK1 inhibitor golidocitinib (DZD4205) and DZD8586 at the 17th International Conference on Malignant Lymphoma (ICML) annual meeting. Golidocitinib: A Promising Treatment for PTCLGolidocitinib, the world’s first and only JAK1 inhibitor in regulatory trial stages, received…
