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SciClone and Menarini Submit NDA for Vaborem in China
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China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this…
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Servier and Google Cloud Extend Partnership to Advance AI in Drug Development
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France-based Servier Group and US technology firm Google Cloud have announced an expansion to their five-year partnership, initially struck in August 2022, by an additional five years. The extension aims to enhance the research and development (R&D) of innovative therapeutic solutions for patients through the utilization of AI and generative…
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Cathay Biotech Plans $901M Private Placement to Boost Bio-Based Materials
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Shanghai-based Cathay Biotech Inc. (SHA: 688065) has announced plans to raise RMB 6.6 billion (USD 901 million) through a private placement of 153,595,531 shares at RMB 42.97 (USD 5.86) per share. This significant capital raise is aimed at enhancing the company’s capabilities in the research, development, manufacturing, and sales of…
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Simcere Licenses Fermion’s AI-Enabled Painkiller FZ002-037
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China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced a licensing agreement with compatriot firm Fermion, an artificial intelligence (AI) empowered small-molecule drug developer, relating to an investigational SSTR4-targeted painkiller candidate drug, FZ002-037. This strategic partnership aims to advance the development and commercialization of FZ002-037 in Greater China, including mainland…
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Boston Scientific’s FARAPULSE and WATCHMAN FLX Studies Show Positive Results
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US major Boston Scientific Corporation (NYSE: BSX) has announced the presentation of positive results from the ADVANTAGE AF study for its FARAPULSE Pulsed Field Ablation (PFA) System and the OPTION study for its WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device at the AF Symposium 2025. These studies highlight the…
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Asieris’ USP1 Inhibitor APL-2302 Cleared for Clinical Trials
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its APL-2302 (ASN-3186) in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced cancer. APL-2302: Mechanism of ActionAPL-2302…
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Zhejiang Huahai’s HB0056 Approved for US Phase I Asthma Trial
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its HB0056. This injectable bispecific antibody (BsAb) targets thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) and is now cleared to enter Phase I clinical study in asthma.…
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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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CSPC’s SYS 6043 Receives FDA Approval for Clinical Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its in-house developed SYS 6043 has obtained clinical trial approval from the US Food and Drug Administration (FDA). This approval marks a significant step forward in the development of innovative treatments for advanced/metastatic solid tumors. Clinical Trial Scope and ObjectivesThe…
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Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its limertinib. This third-generation EGFR TKI has been approved for use in adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer…
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ConjuStar Completes $15 Million Pre-A+ Financing Round
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ConjuStar, a clinical-stage biotechnology company based in Tianjin, China, has announced the completion of a Pre-A+ financing round totaling RMB 100 million (approximately USD 15 million). The round was led by Fosun Health Capital’s New Drug Innovation Fund, with participation from Hengqin Venture Capital and Shenzhen Qianhai Liyuan. Funding and…
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Bio-Thera Solutions Licenses BAT2206 to World Medicine for Turkey
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On January 16, Bio-Thera Solutions Ltd (SHA: 688177), a science – driven innovative global biopharmaceutical company based in Guangzhou, China, announced that it has recently signed a licensing and commercialization agreement with World Medicine for BAT2206. BAT2206 is a biosimilar developed based on Stelara® (ustekinumab). Agreement DetailsUnder the agreement, World…
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GE Healthcare and Sutter Health Form $1B Care Alliance
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) has formed a Care Alliance with compatriot firm Sutter Health, a seven-year tie-up designed to ramp up access to innovative imaging services and create a more seamless and coordinated experience for clinicians and patients across the Sutter…
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HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration (NMPA) has approved another indication for its Orpathys (savolitinib). This approval means that the MET inhibitor can now be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with…
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Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
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China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its IBI343. The latest designation was granted for the TOPO1i anti-CLDN18.2 antibody drug conjugate (ADC) as monotherapy for the treatment…
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Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
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China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed WP107 (huperzine A). The acetylcholinesterase inhibitor is slated to enter a clinical study for the treatment of generalized myasthenia gravis (gMG). WP107: Preclinical…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Biogen Proposes to Acquire Sage Therapeutics for $469M
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US-based Sage Therapeutics, Inc. (NASDAQ: SAGE) has announced that it received an unsolicited, nonbinding proposal from its partner Biogen Inc. (NASDAQ: BIIB) to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen. The proposed acquisition price is USD 7.22 per share. Sage Therapeutics’ Recent PerformanceSage…
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Medtronic Secures Exclusive Distribution Rights for Contego’s Neuroguard and Excipio
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US-Irish firm Medtronic (NYSE: MDT) has entered into an exclusive distribution agreement with Contego Medical, becoming the sole US distributor for Contego’s portfolio of commercially available products. This includes the recently FDA-approved Neuroguard IEP System, a unique 3-in-1 carotid stenting system, and the Excipio Peripheral Thrombectomy Devices. These products are…
