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Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
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Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
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Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
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China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in…
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BeiGene’s Brukinsa Gains NICE Recommendation for CLL Treatment in the UK
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Institute for Health and Care Excellence (NICE) in the UK has issued a final draft guidance (FDG) recommending the company’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for the treatment of eligible adult patients with…
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Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
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China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
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InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
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China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
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Skyline Therapeutics Gains NMPA Approval for SKG0106 in Neovascular AMD Treatment
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Skyline Therapeutics has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug SKG0106, an intraocular injection solution for the treatment of neovascular age-related macular degeneration (nAMD). Innovative Gene Therapy MechanismSKG0106 is a recombinant adeno-associated virus (rAAV) gene therapy drug, utilizing…
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Accuredit Therapeutics Initiates First Dosing of Gene Therapy ART001 for ATTR
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China-based gene therapy start-up Accuredit Therapeutics (Suzhou) Co., Ltd has announced the first dosing of its investigational drug ART001 in seven subjects with transthyretin amyloidosis (ATTR), as part of an investigator-initiated trial (ITT). The drug candidate has demonstrated good safety and achieved a clinically significant decrease in transthyroxine (TTR) protein…
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BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
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The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
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CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
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China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
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AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug Soliris (eculizumab) has received marketing approval in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. This approval marks a significant expansion of Soliris’s application in the Chinese…
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Qilu Pharmaceutical Presents Promising Data for QL1706 and QL1209 at ESMO 2023
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China-based Qilu Pharmaceutical has announced the presentation of clinical data for two of its pipeline candidates, QL1706 and QL1209, at the European Society for Medical Oncology (ESMO) Congress 2023. The data highlights the therapeutic potential of these drugs in treating various forms of cancer, showcasing Qilu’s commitment to innovation in…
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Guangdong Zhongsheng Launches AI Q&A Bot for Leritrelvir Drug Support
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the innovative launch of a smart Artificial Intelligence (AI) Q&A bot for its antiviral drug Yueruiling (leritrelvir). This AI-driven platform is designed to enhance patient support by providing smart Q&A services, an offline drug purchase map guide, and a comprehensive…
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Boehringer Ingelheim’s Vitiligo Drug EI-001 Approved for Clinical Trials by NMPA
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Germany’s Boehringer Ingelheim (BI) has announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) filing for EI-001, a Category 1 vitiligo drug co-developed by Elixiron Immunotherapeutics. This approval marks a significant milestone in the development of new treatment options for vitiligo, a condition that…
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Haisco Pharmaceutical’s HSK21542 Accepted for NMPA Review in Postoperative Pain Management
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for HSK21542, a Category 1 drug, in postoperative analgesia for abdominal surgery has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of HSK21542,…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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MicuRx Pharmaceuticals Initiates Phase I Study for MRX-5 in Australia
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the approval to conduct a Phase I clinical study in Australia to evaluate the safety, tolerability, and pharmacokinetics of its in-house developed antibiotic, MRX-5. The study will also explore the effects of food on the drug’s pharmacokinetics and is expected to conclude in…
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GenScript Reports $152 Million in Sales for Carvykti as of September 30, 2023
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 152 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of September 30, 2023. This represents a year-on-year growth rate…
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Novartis Launches Leqvio in China at RMB 9,988 per Shot
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has officially launched its cholesterol-lowering drug, Leqvio (inclisiran), in China, priced at RMB 9,988 (approximately USD 1,367) per injection. Each pre-filled syringe contains 1.5ml with an effective content of 284mg. The drug is recommended for subcutaneous administration, with a second dose administered three months…
