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Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
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US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. This approval expands their indications to include specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and…
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Pfizer’s Ibrance Demonstrates Significant PFS Improvement in Phase III PATINA Trial
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) and Alliance Foundation Trials, LLC (AFT) have announced positive results from the Phase III PATINA trial for Ibrance (palbociclib), a CDK4/6 inhibitor. The trial data indicated that incorporating Ibrance into the standard-of-care first-line maintenance therapy—following induction chemotherapy—resulted in a statistically significant and clinically…
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BeiGene Ltd Acquires Global Rights to CSPC’s MAT2A Inhibitor SYH2039
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BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has entered into a significant licensing agreement with CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093). The agreement secures BeiGene the global development, manufacturing, and commercialization rights to CSPC’s methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH2039. Financial Details and Milestones of the AgreementAs per…
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Gan & Lee Pharmaceuticals Gets FDA Approval for GZR18 Obesity/Overweight Phase II Study
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase II study for its investigational drug GZR18 in treating obesity and overweight conditions, with and without type 2 diabetes (T2D). GZR18: A Promising GLP-1…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
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HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment from its partner Takeda (TYO: 4502, NYSE:TAK), following the Japanese firm’s achievement of a national reimbursement recommendation for Fruzaqla (fruquintinib) for patients with previously treated metastatic colorectal cancer (CRC) in Spain. This event marks the…
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Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative intravascular dual-mode imaging system, NOVASYNC HYBRID SYSTM. Milestone in Vascular Intervention TechnologyNOVASYNC, a domestic substitute for Grand Pharma’s imported NOVASIGHT HYBRID SYSTEM, signifies a…
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HuidaGene Therapeutics Launches MUSCLE Study for CRISPR Therapy in Duchenne Muscular Dystrophy
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Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced the initiation of the MUSCLE study for its CRISPR-based DNA-editing therapy, HG302, which targets Duchenne muscular dystrophy (DMD), with the first subject now dosed. Understanding Duchenne Muscular Dystrophy and HG302Duchenne muscular dystrophy is a severe X-linked recessive disorder and a prevalent form…
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Sunshine Lake Pharma Files for HKEX IPO, Expanding Global Pharmaceutical Reach
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China-based Sunshine Lake Pharma Co., Ltd has submitted an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKEX), with the unit price and other key details yet to be announced. The exclusive sponsor for this IPO is CICC, a leading financial institution. Established Pharmaceutical Company with a…
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Transcenta’s LIV-1 ADCs Show Promising Results in Pre-Clinical Breast Cancer Study
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) announced updated results from a pre-clinical study for its LIV-1 antibody-based antibody drug conjugates (ADCs) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study focuses on the potential of LIV-1 as a therapeutic target in metastatic breast cancer. LIV-1 as…
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Mabwell Bioscience Secures Licensing Deal with TABUK Pharmaceutical for MENA Region
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has inked a licensing deal with TABUK Pharmaceutical Manufacturing Company, granting the Saudi Arabian company the regulatory filing and commercialization rights to two of Mabwell’s biosimilars in the Middle East and North Africa (MENA) region. The financial details of the agreement were…
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ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its CAR-T-19 injection. This designation is awarded for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients aged 25 and under, marking…
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Grand Pharmaceutical Group Secures Licensing Agreement for CORXEL’s Nasal Sprays in Greater China
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced a significant licensing agreement with compatriot firm Corxel Pharmaceuticals (CORXEL), formerly known as Ji Xing Pharmaceuticals. The agreement grants Grand Pharma exclusive development and commercialization rights to CORXEL’s OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray in Greater China,…
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EOSVISION Ltd Secures Series A Funding to Advance Ophthalmic Implant Development
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Suzhou-based EOSVISION Ltd has reportedly raised close to RMB 100 million (USD 13.78 million) in a Series A financing round, led by Dalton Venture. The proceeds from this investment will be allocated to bolster the company’s research and development (R&D), clinical studies, global development, regulatory filing, and marketing efforts for…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-4729 Peptide Drug
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced the receipt of clinical clearance from China’s National Medical Products Administration (NMPA) for its peptide drug HRS-4729. This development marks a significant step forward in the company’s pipeline of innovative drugs. HRS-4729: A Triple Agonist for Diabetes TreatmentHRS-4729 is a triple…
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VIVA Biotech Expands Global Footprint with New Boston Branch
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China-based Contract Research Organization (CRO) VIVA Biotech (HKG: 1873) has announced the inauguration of its branch in Boston, USA, marking a significant step in the company’s global expansion strategy. Enhancing International Collaboration NetworksThe establishment of the Boston branch is expected to significantly enhance VIVA Bio’s international collaboration networks. This move…
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Siemens Healthineers AG Acquires Advanced Accelerator Applications to Boost PETNET Solutions
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Germany-based Siemens Healthineers AG (ETR: SHL) has announced the completion of its acquisition of Advanced Accelerator Applications (AAA) Molecular Imaging from Novartis (NYSE: NVS). This strategic move is anticipated to significantly enhance Siemens’ PETNET Solutions sector, strengthening its position in the field of positron emission tomography (PET) and radiopharmaceuticals. Enhancing…
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Angitia Biopharmaceuticals Secures USD 120 Million in Series C Financing for Musculoskeletal Treatments
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Angitia Biopharmaceuticals, a provider of solutions for musculoskeletal diseases operating out of Guangzhou, China, and California, the US, has announced the successful closing of a USD 120 million Series C financing round. The funding was led by Bain Capital Life Sciences and included contributions from Janus Henderson and existing investors…
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MDHC Life Technologies Secures Series C++ Funding to Boost Consumer Healthcare and Life Sciences
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China-based Contract Development Manufacturing Organization (CDMO) MDHC Life Technologies (Kunshan) Co.,Ltd has reportedly raised hundreds of millions of renminbi in a Series C++ financing round, led by FUN WAY AMC. The proceeds from this funding will be directed towards the development and operation of the company’s consumer healthcare and life…
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Bayer AG’s Shanghai Co.Lab to Host Epigenic Therapeutics and Peers for CGT Innovation
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Germany-based Bayer AG (ETR: BAYN) has announced that Chinese companies Epigenic Therapeutics, Shanghai Immunocan Biotech Co., Ltd., and AccurEdit Therapeutics will be housed at its Bayer Co.Lab Shanghai. This move aims to leverage Bayer’s global innovation and cooperation network, connecting global pharmaceutical industry resources to boost cell and gene therapy…
