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Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
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The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
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Suzhou Porton Biologics Partners with CorrGene for Cell and Gene Therapy
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China-based contract development and manufacturing organization (CDMO) Suzhou Porton Biologics Ltd has announced a strategic partnership with compatriot firm CorrGene, a rare disease and cancer gene and cell therapy developer headquartered in Wuxi. The collaboration aims to deepen the companies’ involvement in the cell and gene therapy (CGT) field. No…
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Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have…
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Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
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Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
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Junshi Biosciences’ PCSK9 Inhibitor Ongericimab Meets Phase III Endpoints
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) have reached their primary endpoints. The studies focused on primary hypercholesterolemia and mixed hyperlipidemia, demonstrating significant lipid-lowering effects and good safety profiles. Clinical…
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Oricell Therapeutics Closes $45M Series B1 Round for Cellular Immunotherapy
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China-based tumor cellular immunotherapeutics developer Oricell Therapeutics Co., Ltd has announced the closing of a USD 45 million Series B1 investment round. The round was led by premier global industry investors RTW Investments, LP and Qatar Investment Authority, with participation from existing investors, including Qiming Venture Partners and C&D Emerging…
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CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another market filing for its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab. The filing is for the drug’s use in combination with chemotherapy as a first-line treatment of locally advanced or metastatic gastric/gastroesophageal…
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Immorna Closes Series A+ and A++ Rounds Near $100M for mRNA Development
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced the successful closure of Series A+ and A++ financing rounds, raising close to USD 100 million. The funding was led by Guodiao Innovation Private Equity Investment Fund Management (Hainan), Yuexiu Fund, GL Ventures, Zhenji Capital, C&D Emerging Industry Investment, TigerYeah Capital, and others,…
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Sanofi’s VaxigripTetra Approved for Pediatric Influenza Vaccination in China
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical Products Administration (NMPA) for its VaxigripTetra, a tetravalent influenza virus split vaccine, for use in children aged 6 to 35 months. This approval is significant as children are a primary susceptible population to influenza, with…
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Enhertu Approved in China for HER2-Positive Breast Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.…
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Novartis’ Revolade Approved for Severe Aplastic Anemia in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Revolade (eltrombopag olamine tablets). The oral thrombopoietin receptor agonist can now be used to treat severe aplastic anemia (SAA) in patients with inadequate previous remission following immunosuppressive therapy. Revolade:…
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Kelun-Biotech Files for Hong Kong IPO with Goldman Sachs and CITIC Securities
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its high-end preparation subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, has filed an initial public offering (IPO) with the Hong Kong Stock Exchange. The offering is co-sponsored by Goldman Sachs and CITIC Securities, marking a significant step in the company’s…
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Accutar Biotech Begins Phase I Trial for AC0176 in China
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0176, an orally bioavailable chimeric degrader molecule targeting the androgen receptor protein. This marks a significant milestone in the development of innovative treatments for prostate cancer.…
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BeiGene’s Tislelizumab Approved for Gastric Tumors in China
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor tislelizumab has been approved in China as a first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors where PD-L1 is overexpressed. Specifically, tislelizumab is approved for use in combination with fluorouracil plus…
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SciClone Partners with Cowell Health to Enhance Cancer Treatment Accessibility
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has struck a partnership with Cowell Health, Hillhouse Capital’s healthcare-focused wholly-owned subsidiary. The collaboration aims to enhance the accessibility and affordability of high-quality drugs and services, explore a new full-course management model for cancer patients,…
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Baheal Pharmaceutical Partners with Novartis for Votrient Commercialization
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS) to deepen commercialization operations surrounding Novartis’s Votrient (pazopanib). Votrient is a first-line targeted treatment for advanced kidney cancer, offering significant benefits to patients in need. Votrient: Next-Generation TKIVotrient, a next-generation…
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Grand Pharma’s First-in-Class RDC ITM-11 Accepted for IND Review
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China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its first-in-class radionuclide drug conjugate (RDC) ITM-11 has been accepted for review. The intended indication for ITM-11 is gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking a significant step forward in the development of novel treatments…
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Jacobio Pharma Partners with WestChina-Frontier for Preclinical Safety Studies
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China-based Jacobio Pharma (HKG: 1167) has announced a partnership agreement with compatriot firm WestChina-Frontier PharmaTech, a non-clinical research evaluation organization. The collaboration aims to accelerate pre-clinical safety assessment studies for multiple first-in-class drug candidates. Specifically, the two companies will jointly conduct comprehensive toxicological research on multiple preclinical projects, including the…
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Mabwell’s IL-11 Monoclonal Antibody 9MW3811 Approved for Australian Clinical Trial
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from the Therapeutic Goods Administration (TGA) of Australia for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb) for the treatment of various advanced malignant tumors and fibrotic diseases. This approval marks a significant step forward…
