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Suzhou Thery’s Generic Nilotinib Approved by China’s NMPA
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China-based Suzhou Thery Pharmaceutical Inc. has announced that the National Medical Products Administration (NMPA) has approved its generic version of Novartis’s (NYSE: NVS) cancer therapy Tasigna (nilotinib). Thery filed a “4.1 certification” under China’s patent linkage system, directly challenging the validity of Tasigna’s patent. Thery is the first company to…
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Zhifei Biological Products’ BCG Vaccine Filing Accepted by China’s NMPA
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China-based Chongqing Zhifei Biological Products Co., Ltd (SHE: 300122) has announced that its clinical trial filing for an in-house developed therapeutic BCG vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for bladder…
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Yantai Dongcheng Pharma Gets FDA Go-Ahead for 177Lu-LNC1004 Clinical Trial
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its 177Lu-LNC1004 in advanced fibroblast activation protein (FAP)-positive solid tumors. This marks a significant step in the development of this innovative…
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VivaVision Biotech Partners with Everads Therapy for Retinal Disease Therapies
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China’s VivaVision Biotech Inc. has announced a collaboration agreement with Israel-based Everads Therapy Ltd to develop safer, more effective, and lasting novel therapies targeting retinal diseases. The partnership aims to leverage the strengths of both companies to advance innovative treatments for these conditions. Collaboration DetailsThe collaboration is designed to safely…
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Shenzhen-Based Rhegen Bio Raises RMB 100 Million in Pre-Series B Round
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Shenzhen-based biotechnology company Rhegen Bio, specializing in mRNA technology, has reportedly raised RMB 100 million (USD 14.7 million) in a pre-Series B financing round. The funding was led by Fer-Capital Investment, with participation from Sequoia Capital China and other existing investors. The proceeds will be used to support clinical trials…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Denmark
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the health regulatory body in Denmark for its generic version of Roche’s Cytovene-IV (ganciclovir). This approval marks another milestone in the global expansion of Poly Pharm’s product portfolio, targeting the treatment of cytomegalovirus retinitis in immunocompromised…
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Jacobio Pharma Doses First Patient in US Phase I/IIa Study for JAB-2485
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China-based Jacobio Pharma (HKG: 1167) has announced that the first patient has been dosed in a Phase I/IIa clinical study being carried out in the United States for its Aurora A inhibitor JAB-2485. The initial indication for the study is general advanced solid tumors, marking a significant step in the…
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VACSERA in Talks with Sinovac to Establish Integrated Vaccine Plant
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Egypt-based drug firm Holding Company for Biological Products and Vaccines (VACSERA) is reportedly in talks with China-based Sinovac Biotech Ltd (NASDAQ: SVA) to establish an integrated manufacturing plant focused on vaccines, according to a local media source. The proposed facility aims to enhance vaccine production capabilities and address the growing…
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Eisai CEO Outlines Ambitions for Alzheimer’s Drug Leqembi After FDA Approval
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Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc’s (NASDAQ: BIIB) novel Alzheimer’s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. According to Naito, the US market eligible to use Leqembi annually currently stands…
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Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
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Luye Pharma’s BA1301 Receives CDE Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This…
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HutchMed’s Sovleplenib Administered to First Patient in Phase II COVID-19 Study
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On January 4, Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) administered its novel, investigational, selective small-molecule inhibitor sovleplenib to the first patient at Huashan Hospital. The Phase II study is focused on severe/critical COVID-19 patients, marking a significant step in the development of this innovative therapy. Mechanism and DevelopmentSovleplenib…
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Zai Lab and Novocure’s TTFields Device Shows Survival Benefit in Lung Cancer Study
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Shares in Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) and its partner Novocure (NASDAQ: NVCR) surged yesterday after the companies revealed positive results from the Phase III LUNAR study. The study assessed the efficacy of the TTFields electrical field medical device in combination with immunotherapy for patients with…
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Salubris Pharmaceuticals Gains NMPA Approval for Phase I Study of SAL0133
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its 3CL protease inhibitor SAL0133 in adult patients with mild to common COVID-19. This marks a significant step forward in the development of…
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Kactus Biosystems Partners with Bioheng for Cell Therapy Raw Materials
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Shanghai-based Kactus Biosystems, a firm specializing in target proteins and raw enzymes, has announced a partnership with Nanjing Bioheng Biotech Co., Ltd to develop and domesticate raw materials for cell therapies. The collaboration focuses on the process development and raw materials domestication of universal chimeric antigen receptor (CAR)-T therapies. Bioheng,…
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Immune-Onc Therapeutics Completes $131 Million Series B Financing
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US-headquartered Immune-Onc Therapeutics, Inc. has announced the successful completion of a Series B financing round totaling USD 131 million, including a USD 25 million extension. The extension was led by existing investor Triwise Capital, with participation from new investors such as Proxima Ventures. Additionally, the company received continued strategic capital…
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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Singular Medical Secures Series B+ Funding for Cardiac Device Development
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Singular Medical, a Suzhou-based maker of cardiac rhythm and heart failure devices, has reportedly raised “hundreds of millions” of renminbi in a Series B+ financing round. The funding was led by Lotus Lake Capital and Kangyu Capital, with participation from existing investor Qiming Venture Partners. The proceeds will be used…
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Boehringer Ingelheim Enrolls First Patient in Phase II/III Study for BI 907828
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German pharmaceutical giant Boehringer Ingelheim has announced the enrollment of the first patient in the Phase II/III Brightline-1 study for its investigational MDM2-p53 antagonist BI 907828. The study is taking place at the West China Hospital and aims to assess the efficacy and safety of BI 907828 compared to doxorubicin…
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Vcanbio’s Stem Cell Therapy VUM02 Accepted for Clinical Trial Review
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) has been accepted for review by the Center for Drug Evaluation. VUM02 is a Category 1 therapeutic biologic product developed to treat patients with…
