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Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…
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Kamari Pharma Completes $8M Investment from Chinese Fund GIBF2
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Israel-based Kamari Pharma has announced the completion of an $8 million investment from the Chinese fund GIBF2. This brings the total funds raised by Kamari to $16 million. The company was established at the end of 2018 by leading Israel-based biotech funds Pontifax and Arkin Bioholdings. Kamari develops topical and…
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Joincare’s Modified Drug XYP-001 Gains NMPA Approval for IPF Trial
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its modified drug XYP-001 inhaler. The targeted indication is idiopathic pulmonary fibrosis (IPF). Disease Overview and Current TherapiesIPF is a chronic progressive fibrotic interstitial…
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Koutech Robotics Secures Series A Funding for Surgical Innovation
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China-based Koutech Robotics (Shanghai) Co., Ltd, a leading ultra-micro, high-precision surgical robot platform company, has reportedly raised “hundreds of millions” of renminbi in a Series A financing round. The round was led by Qiming Venture Partners, with contributions from Proxima Ventures, DNE Capital, Lingang Blue Bay Fund, Winfast Holding, and…
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CARsgen Therapeutics Presents Positive Phase Ib/II Data for CT053 at CAR-TCR Summit
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China-based CARsgen Therapeutics Holdings Ltd presented the results of a multi-center, open-label Phase Ib/II study assessing the safety and efficacy of its B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T cell therapy CT053 (zevor-cel) at the 7th CAR-TCR Annual Summit. The study is being conducted across North America, focusing…
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Joincare Pharmaceuticals Prices GDRs on SIX Swiss Exchange
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has priced its Global Depository Receipts (GDRs) on the SIX Swiss Exchange at $14.42 per share. The company aims to raise $92.04 million through the issuance of 638.25 million GDRs. GDR Issuance DetailsThe GDRs will be available for trading on September…
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Northeast Pharmaceutical to Invest in Shanghai Subsidiary for ADC and CAR-T Development
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China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has announced plans to invest RMB 500 million ($71 million) in establishing a wholly-owned subsidiary in Shanghai. The new entity is designed to accelerate the implementation of in-licensed antibody drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies, following a recent ADC-focused…
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Beijing Designates 923 Medical Entities for National Reimbursement Drug List
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The Beijing Municipal Medical Insurance Bureau has released a notification indicating that a total of 923 medical entities are now designated for coverage under the National Reimbursement Drug List (NRDL). The document is open for public feedback from September 19 to September 26. Designated EntitiesAmong the designated entities are 169…
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Lee’s Pharmaceutical Reports H1 Revenue Growth Amid Product Portfolio Shift
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has released its H1 2022 interim financial report, recording HKD 649 million ($82.6 million) in revenue, up 11.1% year-on-year (YOY). The growth was driven by products such as Bredinin (mizoribine), treprostinil, and interferon α2b, which offset declining sales of Ferplex (iron protein succinylate)…
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Junshi Biosciences’ Tuoyi Approved for First-Line NSCLC Treatment in China
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China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi (toripalimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in tumors with no EGFR/ALK mutations, in combination with chemotherapy. This marks the sixth indication approval for the programmed death-1 (PD-1) inhibitor in…
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Sun-Novo’s STC007 Gains NMPA Approval for Postoperative Pain Study
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007 for postoperative pain. This marks a significant milestone in the development of this innovative therapy. Drug Mechanism…
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WuXi Biologics Partners with Elpiscience for Macromolecule Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced multiple partnerships with compatriot firm Elpiscience Biopharmaceuticals Inc. WuXi Bio will be involved in Elpiscience’s process development and pilot test facilities in Suzhou, facilitating their transformation into a top-tier macromolecule development and GMP compliant service base.…
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Tasly Pharmaceuticals Gains NMPA Approval for B1344 Diabetes Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this…
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Clover Biopharmaceuticals Reports Positive Phase III Data for COVID-19 Vaccine SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced additional positive Phase III clinical trial data for its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The data show that subjects who received SCB-2019 as the third booster, following two doses of inactivated vaccine, exhibited higher levels…
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RemeGen Announces Positive Phase III Results for Telitacicept in SLE
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China-based pharma firm RemeGen (HKG: 9995) has announced the conclusion of a Phase III confirmatory study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE) in China, releasing preliminary data. The study enrolled 335 patients, randomized to receive telitacicept (160mg) or placebo via subcutaneous injection once per week…
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BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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Beijing Launches HIV Precision Medicine Standardization Project
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On September 17, an HIV precision medicine standardization project was initiated in Beijing. The project, led by the National Center for Infectious Diseases (NCID) and the China National Health Association (CNHA) and sponsored by Gilead Sciences, aims to enhance the quality of HIV outpatient services in hospitals. The initiative seeks…
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Fosun Pharma Signs Exclusive Licensing Deal for H008 with Carephar
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has signed an exclusive licensing deal with compatriot firm Jiangsu Carephar Pharmaceutical Co., Ltd to develop H008 globally, including its oral preparation and injection forms, and covering all plausible indications. Agreement Details and Rights AllocationUnder the agreement, Carephar will…
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Suzhou Weiyou Gene Bio Raises Pre-Series A Funding for Gene Therapy Pipeline
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China-based Suzhou View Gene Biotechnology Co., Ltd has reportedly raised “tens of millions” of renminbi in a pre-Series A financing round. The round was led by Proxima Ventures, with proceeds directed towards clinical studies, new adeno-associated virus (AAV) carrier design, pilot-scale production line construction, and expansion of the gene therapy…
