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Chengdu Hyperway Pharmaceuticals’ HBW-004285 Gets NMPA Tacit Approval for Pain Treatment
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China-based Chengdu Hyperway Pharmaceuticals has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its Nav1.8 inhibitor, HBW-004285, which is intended for the treatment of acute and chronic pain. Understanding the Role of Nav1.8 in Pain SignalingNav1.8 is a tetrodotoxin-insensitive voltage-gated sodium ion channel that…
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Shanghai Bio-Heart’s Iberis RDN System Meets Primary Endpoint in Iberis-HTN Study
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Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced that its Iberis multi-electrode renal radiofrequency denervation (RDN) system has successfully reached its primary clinical endpoint in the randomized, controlled Iberis-HTN study for the treatment of primary hypertension. Iberis-HTN Study ResultsThe prospective, multicenter, blinded, randomized controlled trial was designed to…
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Grand Pharmaceutical’s APP13007 Achieves Clinical Endpoints in US Trials for Post-Operative Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that a Phase II clinical study and two Phase III clinical studies for its APP13007, a modified hormone nano suspension eye drop, have successfully reached their clinical endpoints in the United States. The clinical results demonstrate that APP13007 exhibits significant efficacy…
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Sirnaomics Commences Phase I Clinical Trial for Factor Xl RNAi Drug STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the commencement of a single-center, randomized, double-blind, placebo-controlled, sequence grouping Phase I clinical study for its factor Xl-targeted RNAi drug, STP122G. The US-based trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy subjects initially, before expanding to its…
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Shanghai Fosun Pharmaceutical Submits Market Approval Filing for Daxibotulinumtoxin A in China
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug is intended for use in the temporary improvement of moderate to severe frown lines in adults, attributed…
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Junshi Biosciences’ Senaparib Meets Primary Endpoint in Phase III Ovarian Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with Impact Therapeutics Inc., has achieved the pre-set optimal efficiency threshold, marking the trial’s primary endpoint. The study targets the first-line maintenance treatment for stage III/IV ovarian cancer,…
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Porton Pharma Solutions Expands with Biomacromolecules R&D and Manufacturing Center in Shanghai
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China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions has initiated the construction of a state-of-the-art biomacromolecules research and development (R&D) and manufacturing center in the Wai Gao Qiao Tax-Free Zone of Shanghai. This new facility aims to offer biopharmaceutical companies and new drug developers comprehensive one-stop CDMO services,…
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Blueray Med Secures Tens of Millions in Series A+ Financing for Advanced Laser Medicine Devices
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Blueray Med, a leading high-end laser medicine device manufacturer based in Xi’an, has reportedly secured tens of millions of renminbi in a Series A+ financing round. The round was led by Hefei Zhonghe Oupu Medical, with the Health Industry Fund Partnership and Shaanxi Investment Fund participating as leading investors. The…
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Specialised Therapeutics to Commercialize Akeso’s PD-1 Inhibitor Penpulimab in APAC
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Singapore-based Specialised Therapeutics Asia Pte Ltd (ST) has been appointed to handle the commercialization of the programmed death-1 (PD-1) inhibitor, Anniko (penpulimab), in Australia, Singapore, and South-East Asia. The drug is developed by the joint venture (JV) CTTQ-Akeso (Shanghai) Biomed Tech Co., Ltd, a partnership between Akeso Inc. (HKG: 9926)…
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Legend Biotech Appoints Dr. Mythili Koneru as Chief Medical Officer to Lead Clinical Development
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced the appointment of Dr. Mythili Koneru as its new Chief Medical Officer (CMO). In this role, Dr. Koneru will be responsible for leading the company’s clinical development and medical affairs programs, further strengthening Legend’s executive team. Dr. Koneru’s Background and ExperienceDr. Koneru…
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Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
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China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its biosimilar version of Roche’s Avastin (bevacizumab) has been accepted for review by Brazil’s National Health Surveillance Agency (ANVISA). Luye’s Biosimilar Approval and Global OutlookLuye’s biosimilar bevacizumab was approved in China in 2021 to treat indications…
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Bristol-Myers Squibb Launches Zeposia in China for Multiple Sclerosis Treatment
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Global pharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced the market launch in China of Zeposia (ozanimod), the world’s first selective sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of recurrent multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. Mode…
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Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
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JW Therapeutics’ Carteyva Receives NMPA Approval for Moderate-to-Severe SLE Clinical Trial
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China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its product Carteyva (relmacabtagene autoleucel injection; relma-cel). The treatment will be assessed for its efficacy in managing moderate-to-severe refractory systemic lupus erythematosus (SLE). Understanding Systemic Lupus Erythematosus (SLE)SLE is a…
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Hua Medicine Partners with 111 Inc. for Dorzagliatin Sales and Distribution in China
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China-based Hua Medicine (HKG: 2552) has announced a sales and distribution agreement with online pharma retailer 111 Inc., enabling the latter to sell Hua Medicine’s dorzagliatin on its platform from April 7, 2023, to December 31, 2023. Hua Medicine will charge a fee of not more than RMB 40 million…
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CStone Pharmaceuticals Reduces Ayvakit Price to Boost Accessibility in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a lower recommended price for its precision medicine drug Ayvakit (avapritinib) in an effort to alleviate the financial burden on patients and enhance drug accessibility. The new prices for the 100mg and 300mg versions of the drug are now set at RMB 17,207…
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Hangzhou Baikai Biomedical and Leads Biolabs Partner to Develop Innovative ADCs
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China-based Hangzhou Baikai Biomedical Co., Ltd and Leads Biolabs Inc. have announced a partnership aimed at developing multiple novel antibody-drug conjugates (ADCs). The collaboration combines the expertise of both companies to advance the development of innovative cancer treatments. Financial details of the partnership have not been disclosed. Baikai Bi’s ADC…
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Cuban-Chinese Biotechnology Center Showcases Drug and Vaccine Progress to Cuban Delegation
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Researchers from Cuba and China at the Yongzhou joint biotechnology innovation center in China’s Hunan Province recently presented updates on their drug and vaccine development projects to a diplomatic delegation from Cuba. Established in 2021, the bi-national institution has a robust pipeline that encompasses cancer, neurology, and infectious diseases, including…
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Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
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The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig (ponatinib) is on track to obtain priority review status for the treatment of specific leukemia conditions in China. These include chronic myeloid leukemia (CML) that is resistant or intolerant to previous medications, recurrent or refractory…
