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Genesis MedTech’s iReach Omnia Receives NMPA Approval for Rectal Cancer Surgery
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Singapore-based medical device company Genesis MedTech has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its groundbreaking device, the iReach Omnia. This marks a significant milestone as iReach Omnia is the world’s first powered stapler with 90° articulation capability. Enhancing Surgical Precision in…
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Eli Lilly & Co. Launches Mounjaro (Tirzepatide) in China for Diabetes and Weight Management
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US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the official market launch of its drug Mounjaro (tirzepatide) in China, expanding access to this treatment for patients in the region. Coverage of Two IndicationsThe launch of Mounjaro in China covers two specific indications. The first is for the…
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Prime Gene Therapeutics Secures Over RMB300 Million in Series B Financing
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Beijing-based Prime Gene Therapeutics Co., Ltd (873969.NQ), a clinical-stage biotech company specializing in immune inflammatory diseases, has reportedly raised over RMB300 million (USD41 million) in a Series B financing round. The investment was led by a consortium of prominent financial backers, including Beijing Medical and Health Industry Investment Fund, E-town…
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Brii Biosciences to Acquire Full Rights to BRII-179 from VBI Vaccines
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China-based Brii Biosciences Ltd (HKG: 2137) has announced its intention to acquire the intellectual property (IP) and other assets related to BRII-179 from its US partner VBI Vaccines, Inc. and certain of its subsidiaries (VBI), as well as its creditor K2 VBI Equity Trust, LLC and K2 HealthVentures LLC. Comprehensive…
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Shanghai Pharmaceuticals Halts Development of I001-B, I022, and C012 in the US
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China’s Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607) has declared the termination of clinical trials and subsequent development of I001-B (US), I022 (US), and C012 (US). This decision comes after a comprehensive evaluation of the future market value, business collaboration, and development investment required for these projects. I001-B and I022…
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Astellas Pharma’s Vyloy Approved by NMPA for CLDN18.2 Positive Gastric Cancer
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China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive,…
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Sichuan Kelun-Biotech’s Ketailai Receives NMPA Approval for Nasopharyngeal Carcinoma Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb), Ketailai (KL-A167). This treatment is now approved for use in recurrent or metastatic nasopharyngeal carcinoma (NPC) patients…
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Sino Biopharmaceutical’s Chia Tai Tianqing Secures Exclusive Promotion Rights for Naldemedine in China
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced an exclusive market promotion agreement between its subsidiary Chia Tai Tianqing and Ping An-Shionogi Co., Ltd, a joint venture between China-based commercial insurance firm Ping An Insurance (Group) Ltd and Japanese pharmaceutical firm Shionogi & Co., Ltd. Under this initially 11-year accord,…
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HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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Innovent Biologics Strikes Licensing Deal with Roche for IBI3009 ADC
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a significant licensing agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The agreement grants Roche global exclusive development, manufacturing, and commercialization rights to Innovent’s IBI3009, a DLL3-targeted antibody drug conjugate (ADC) that is anticipated to offer new treatment options for patients with…
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Maxvax Biotechnology Secures RMB 200 Million in Convertible Bonds Financing
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Immunotherapy biotech company Maxvax Biotechnology, based in Chengdu, has announced the successful closure of a convertible bonds financing round, raising RMB 200 million (USD 27.4 million). The financing was subscribed to by the Shenzhen Capital Group Manufacturing Industry Transformation and Upgrading New Materials Fund, highlighting the investor’s confidence in Maxvax’s…
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Zhaoke Ophthalmology’s TAB014 Achieves Positive Phase III Results for wAMD
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III study for its core candidate drug TAB014 in the treatment of wet (neovascularization) age-related macular degeneration (wAMD). The study successfully met all primary and key secondary endpoints,…
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HutchMed to Divest 45% Stake in Shanghai Hutchison Pharmaceuticals for $608 Million
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has reached an agreement to divest its 45% equity interest in Shanghai Hutchison Pharmaceuticals Limited (SHPL) to GP Health Service Capital Co., Ltd and Shanghai Pharmaceuticals Holding Co., Ltd. (SPH, HKG: 2607, SHA: 601607) for a combined total of USD608 million. Background…
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Boston Scientific Launches Athletis Peripheral Balloon Dilatation Catheter in China
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US-based medical device leader Boston Scientific Corporation (NYSE: BSX) has announced the market launch of its Athletis peripheral balloon dilatation catheter in mainland China. This product is designed for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system and is utilized in the treatment of stenotic lesions in autologous or…
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Alphamab Oncology’s JSKN033 Advances to Phase III Trial for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
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Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema
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Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II…
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Johnson & Johnson’s Rybrevant Combo Approved by EC for First-Line NSCLC Treatment
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US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that the European Commission (EC) has granted label extension approval for its Rybrevant (amivantamab) combined with Lazcluze (lazertinib) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletions…
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BeiGene Secures Global Rights to Duality Biologics’ B7H4 Targeted ADC DB1312/BG-C9074
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Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has announced that BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has exercised its exclusive option to secure global development, manufacturing, and commercialization rights to Duality’s B7H4 targeted antibody-drug conjugate (ADC), DB1312/BG-C9074. Terms…
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Novartis Announces Positive Results from Phase III STEER Study on SMA Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III STEER study, which was designed to assess the efficacy and safety of its intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2. The study focused on patients aged two…
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Xtalpi Inc. Partners with Amazon Web Services to Accelerate Life Sciences Innovation
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Shenzhen-based QuantumPharm Inc., operating under the name Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with US-based Amazon Web Services (AWS). AWS will serve as Xtalpi’s cloud service provider, empowering the company to enhance its innovative development in life science, chemistry, and new materials through the use of artificial…
