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Ascendis Pharma’s TransCon hGH sBLA for Adult GHD Accepted by FDA
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Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for TransCon hGH (lonapegsomatropin-tcgd) for the treatment of adult growth hormone deficiency (GHD). The FDA’s decision is anticipated by the Prescription Drug User Fee…
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Alibaba Health Reports 10.2% Revenue Growth and 72.8% Profit Increase in 2024 H1 Financials
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China-based Alibaba Health Information Technology Ltd (HKG: 0241) has released its financial report for the first half of 2024, ending September 30, 2023. The company recorded revenues of RMB 14.273 billion (USD 1.96 billion) and profits of RMB 769 million (USD 106 million), marking an increase of 10.2% and 72.8%…
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Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
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Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on its label extension bid for Ozempic (once-weekly subcutaneous semaglutide). The company is seeking to expand the indication of the GLP-1 receptor…
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Bayer AG Initiates Phase I Study Combining BAY3498264 with Sotorasib for KRAS-Mutated Tumors
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Germany-based pharmaceutical giant Bayer AG (ETR: BAYN) has announced the initiation of a Phase I study to assess the preliminary efficacy and safety of its BAY3498264, a selective SOS1 inhibitor, when combined with sotorasib in patients with advanced KRAS G12C-mutated solid tumors. BAY3498264: A Potential Therapeutic Agent for KRAS-Mutant CancersBAY3498264…
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CureGene Pharmaceutical Gets NMPA Approval for Antiplatelet Drug CG-0255
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Shanghai-based CureGene Pharmaceutical has announced receiving clinical trial approval from China’s National Medical Products Administration (NMPA) for its innovative antiplatelet drug, benzenesulfonate CG-0255. This development marks a significant step forward for the company and its efforts to bring a new treatment option to patients with acute coronary syndrome (ACS). Category…
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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…
