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CMS’s Rxilient Medical Licenses Insulin Products from Hefei Tianmai Biotech
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China Medical System Holdings (CMS; HKG: 0867) announced that its subsidiary Rxilient Medical Pte. Ltd has entered into a licensing, collaboration, and supply agreement with Hefei Tianmai Biotechnology Co. Ltd regarding its second-generation insulin and third-generation insulin analogue insulin glargine. Under the agreement, CMS will hold exclusive licensing rights to…
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Kelun Pharmaceutical Receives USD 35 Million from Merck Sharp & Dohme Corp.
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that it has received a USD 35 million payment from US-based Merck Sharp & Dohme Corp. (MSD), in accordance with the licensing agreement signed in July this year. Under the agreement, MSD has obtained global development, manufacturing, and commercial rights to…
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Hainan Yuekang’s YK-029A Biosimilar Set for BTD in EGFR ex20ins NSCLC
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The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co., Ltd’s YK-029A, a biosimilar of Tagrisso (osimertinib), is set to gain Breakthrough Therapy Designation (BTD) status for use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (EGFR ex20ins). YK-029A, an…
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Walvax Biotech Enrolls First Subject in Phase III HPV Vaccine Study
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) announced the first subject enrollment for a Phase III clinical study assessing the immunogenicity of its in-house developed nine-valent human papillomavirus (HPV) vaccine compared with Merck Sharp & Dohme’s (MSD) Gardasil 9. The vaccine is designed for the prevention of cervical cancer, vulvar…
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Sinocelltech’s Ripertamab Officially Launched in China for DLBCL Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the first deliveries and prescriptions of its ripertamab (SCT400), marking the official national launch of the drug in China. The innovative CD20 monoclonal antibody (mAb) is described as similar in efficacy and safety to rituximab and was approved on August 31 for treating…
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Innovent’s Tyvyt Shows PFS Benefit in EGFR-Mutant NSCLC at ESMO
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China-based Innovent Biologics, Inc. (HKG: 1801) presented results of the ORIENT-31 study for its PD-1 inhibitor Tyvyt (sintilimab) at the 2022 European Society for Medical Oncology (ESMO) annual meeting. The study evaluated Tyvyt, with or without Bevagen (bevacizumab), a biosimilar version of Avastin, in combination with chemotherapy for EGFR-mutant non-squamous…
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Luye Pharma’s CD25 Monoclonal Antibody BA1106 Gains NMPA Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s in-house developed CD25 monoclonal antibody (mAb) BA1106 has received clinical trial approval from the National Medical Products Administration (NMPA). This makes BA1106 the first CD25-targeted drug to enter clinical trials in China for the treatment…
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Fosun Pharma Inks Licensing Deal with Neovii for GvHD Therapy Grafalon
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) signed an exclusive licensing agreement with Swiss firm Neovii Pharmaceuticals AG, focusing on Neovii’s graft versus host disease (GvHD) therapy Grafalon (rabbit anti-human T-lymphocyte globulin, ATLG). Under the deal, Fosun gains development and commercialization rights to Grafalon in Greater…
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Fudan-Zhangjiang’s JAK1 Inhibitor FZJ-003 Gel Enters Phase I Trial for Atopic Dermatitis
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China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349, SHA: 688505) announced that a Phase I clinical trial filing for its topical JAK1 selective inhibitor FZJ-003 gel (specification: 1%, 2%) in atopic dermatitis (AD) has been accepted for review. Global JAK Inhibitor MarketGlobally, nine JAK inhibitors are currently marketed, including Sanofi/Incyte’s…
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HutchMed’s Elunate Shows Survival Benefit in Global CRC Study at ESMO
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the results of the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) at the European Society for Medical Oncology (ESMO) 2022 annual meeting. Study Design and ResultsThe multi-center…
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Jacobio’s KRAS G12C Inhibitor JAB-21822 Advances to Pivotal Phase II in NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has received approval from the National Medical Products Administration (NMPA) to launch a pivotal Phase II trial of its KRAS G12C inhibitor, JAB-21822, for advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. The company plans to file…
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Lianren Digital Health Partners with Ningbo Government on Health Data Ecosystem
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Shanghai-based Lianren Digital Health has forged a strategic partnership with the People’s Government of Ningbo Municipality, announced at the World Digital Economy Conference 2022. The collaboration aims to enhance Ningbo’s healthcare digital infrastructure and data utilization, with no financial terms disclosed.Partnership Goals The alliance will focus on three pillars:Upgrading health…
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Bio-Heart Invests RMB 50M in Cardiotek to Advance Balloon-Expandable TAVR Device
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Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185), a leading Chinese interventional cardiovascular device maker, will invest RMB 50 million (USD 7.2 million) in compatriot firm Cardiotek HK Ltd, securing a 9.09% stake. The deal underscores Bio-Heart’s expansion into transcatheter aortic valve replacement (TAVR) technology, complementing its core bioresorbable scaffold…
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HitGen’s Vernalis Subsidiary Collaborates with Unison Medicines on Undruggable Bacterial Target
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China’s HitGen Inc. (SHA: 688222) announced a strategic research collaboration between its wholly owned subsidiary, Vernalis Research, and U.S.-based Unison Medicines Inc., targeting an undisclosed bacterial pathogen previously deemed “undruggable.” The partnership leverages Vernalis’ drug discovery expertise to design small-molecule therapies, with Unison funding all R&D activities and sharing downstream…
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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Shows Superior Booster Efficacy in Phase III Trial
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) reported positive Phase III trial results for its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The study demonstrated superior neutralizing antibody responses against the wild strain and Omicron subvariants BA.1/BA.2 compared to homologous inactivated vaccine boosters. Trial Design and ResultsThe…
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Astellas’ Fezolinetant Hits Menopause Trial Goals in China, Eyes Global Launch
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Japan’s Astellas Pharma Inc. (TYO: 4503) announced positive results from a Phase III trial of fezolinetant, its experimental therapy for menopause symptoms, in China. The 52-week MOONLIGHT 3 study met primary endpoints for safety and efficacy in treating severe vasomotor symptoms (VMS), positioning the drug as a potential first-in-class treatment…
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CellOrigin and Qilu Partner on Global CAR-iMAC Cancer Therapy Development
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CellOrigin Biotech (Hangzhou) Co., Ltd, a China-based biotech firm specializing in allogeneic cell therapies, has signed a global collaboration with Qilu Pharmaceutical to develop “off-the-shelf” chimeric antigen receptor macrophages (CAR-iMACs) for cancer immunotherapy. Financial terms of the agreement were not disclosed. Strategic Partnership and R&D SynergiesThe partnership combines CellOrigin’s expertise…
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Bio-Heart Plans STAR Board IPO After Hong Kong Debut to Advance Cardiovascular Therapies
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Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185), a leading Chinese innovator in interventional cardiovascular devices, has announced plans for an initial public offering (IPO) on Shanghai’s Sci-Tech Innovation Board (STAR) following its HKD 440 million (USD 56 million) Hong Kong debut in November 2023. The move underscores the company’s…
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Fosun Pharma’s Controlling Shareholder to Sell 3% Stake for USD 461 Million
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) announced that its controlling shareholder, Shanghai Fosun High Technology (Group) Co., Ltd—a subsidiary of Fosun International—is set to sell a holding of 80 million shares, or a 3% stake, in the firm. The sale is expected to bring in RMB 3.22 billion…
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SciClone Pharmaceuticals Doses First Patient in RRx-001 Phase III Study for SCLC
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China-based SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) announced that the first patient has been dosed in the Phase III regulatory REPLATINUM study in China for its RRx-001, a next-generation small-molecule immunotherapy targeting CD47/SIRPα (signal-regulatory protein alpha). The drug, in-licensed from US firm EpicentRx Inc. in July 2020, is being evaluated as…
