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Ji Xing Pharmaceuticals and TSH Biopharm Announce Collaboration for Dry Eye Treatment in Taiwan
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Shanghai-based Ji Xing Pharmaceuticals, a company backed by RTW Investments, has announced a strategic collaboration agreement with Taiwan-headquartered TSH Biopharm (TSH). Under this agreement, TSH will provide commercialization support for varenicline solution nasal spray (US brand name Tyrvaya) in Taiwan. The financial details of the collaboration were not disclosed. Varenicline…
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Hrain Biotechnology’s Anti-CD70 T Cell Therapy HR010 Gets Tacit Approval for Renal Cancer Trial
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Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
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Huadong Medicine’s Elahere Receives Approval for FRα Positive Cancer Treatment in China
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval to introduce Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), at Ruijin Hospital’s Hainan branch. The treatment is indicated for FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in…
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WuXi Biologics Proposes Spin-Off and Listing of WuXi XDC on Hong Kong Stock Exchange
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced the proposed spin-off and separate listing of its subsidiary, WuXi XDC Cayman Inc. (WuXi XDC, HKG: 2268), on the Hong Kong Stock Exchange’s Main Board. WuXi XDC’s Specialized Services in Bioconjugates and ADCsWuXi XDC, a joint…
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Jiangxi Jemincare Group Launches Omalizumab Biosimilar CMAB007 in China for Asthma and Dermatology
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Jiangxi Jemincare Group has overseen the official launch and first prescription of its omalizumab biosimilar, CMAB007, a version of Roche/Genentech’s (SWX: ROG) anti-IgE dermatology and asthma therapy Xolair, in Beijing. The drug’s launch comes less than two months after it received market approval. Therapeutic Applications of OmalizumabOmalizumab is utilized to…
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Zhejiang Doer Biologics Partners with BioNTech for Global Development of Innovative Biological Drugs
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Zhejiang Doer Biologics Co., Ltd, a China-based clinical-stage biopharmaceutical company, has announced a significant licensing agreement with Germany’s BioNTech SE (NASDAQ: BNTX). Under the terms of this deal, Doer Bio will provide BioNTech with a global license to research, develop, manufacture, and commercialize innovative biological drugs targeting an undisclosed therapeutic…
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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
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Sino Medical Sciences Receives Approval for Next-Generation Drug-Eluting Stent in Indonesia
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approval for its next-generation drug-eluting stent system, BuMA Supreme, in Indonesia. The product is approved for use in improving the symptoms of vascular stenosis and will be eligible for marketing until October 19, 2027. Composition and Design of…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
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Everest Medicines and Sinopharm Group Ink MoU to Enhance Distribution and Collaboration
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China-based Everest Medicines (HKG: 1952) has announced the signing of a memorandum of understanding (MoU) with Sinopharm Group Co., Ltd. The partnership aims to capitalize on Sinopharm’s supply chain service advantages in distribution, access, and retailing for Everest’s listed products within mainland China. The collaboration will also explore new product…
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BeiGene Secures Exclusive Licensing Deal with Duality Biotherapeutics for Novel Drug Development
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced an exclusive option and licensing agreement with Duality Biotherapeutics, a novel modality drug developer with operations in both the United States and China. This strategic partnership aims to leverage Duality’s expertise in developing innovative therapies. Financial Terms and MilestonesAccording to…
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Bayer and Peking University Enter Fourth Phase of Partnership to Advance Drug Discovery
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Germany-based pharmaceutical giant Bayer (ETR: BAYN) has entered its fourth phase of partnership with the esteemed Peking University. This collaboration aims to strengthen the translation of basic research in key medical fields, including oncology, cardiovascular disease, kidney disease, immunity, and cell and gene therapy, with the goal of generating novel…
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Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
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China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug Evaluation (CDE) and South Korea’s Ministry of Food and Drug Safety (MFDS) for their pipeline candidate osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. Both regulatory bodies have approved the plan for TranStar 301, a global Phase…
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Pentax Medical to Establish Endoscope Manufacturing and R&D Site in Shanghai
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Japan-based Pentax Medical, a division of the Hoya Group specializing in endoscopic products, has announced plans to establish a new site in China focused on endoscope manufacturing, research and development (R&D), and the provision of related services. The facility will be located in Shanghai under the umbrella of Pentax Medical…
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Sinopep-Allsino Bio Pharmaceutical Cuts Fundraising Target to RMB434 Million via Convertible Bonds”
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Jiangsu-based Contract Development and Manufacturing Organization (CDMO) Sinopep-Allsino Biopharmaceutical Co., Ltd has revised its proposal for a convertible bond issuance, now expecting to raise RMB434 million, a decrease of RMB100 million compared to the initial target of RMB534 million set in November 2022. Proceeds Allocation for Strategic Projects and Working…
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Shanghai BDgene Technology Receives US FDA Approval for HSV-1 Stromal Keratitis Gene Therapy
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced receiving approval from the US FDA to conduct a clinical study for its pipeline candidate, BD111, in the treatment of type I herpes simplex virus (HSV-1) stromal keratitis. HSV-1 is a pathogen responsible for a range of diseases, including oral…
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Jenscare Scientific’s LuX-Valve Plus Accepted for US FDA Review in IDE Process
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Ningbo-based structural heart disease intervention device manufacturer, Jenscare Scientific Co., Ltd (HKG: 9877), has announced that the early feasibility study (EFS) pre-submission for its LuX-Valve Plus has been accepted for review by the US FDA. This filing marks the initiation of the Investigational Device Exemption (IDE) process in the United…
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Broncus Medical Inc. Launches First Regulatory Clinical Study for Targeted Lung Denervation System
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China-based Broncus Medical Inc., (HKG: 2216), a provider of precision intervention solutions focused on lung diseases, has announced the start of its first regulatory clinical study for its targeted lung denervation (TLD) radiofrequency ablation system. This multi-center, randomized study will be conducted across 26 centers, aiming to assess the safety…
