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Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP). Mechanism of Action and Broader Implications…
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BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
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BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
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Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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Asieris Pharma Launches Generic Votrient for Renal Cell Carcinoma in China
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd, trading as Asieris Pharma (SHA: 688176), has announced the issuance of the first prescription for its generic version of the UK pharmaceutical major GSK’s (NYSE: GSK) Votrient (pazopanib) in China. This milestone not only marks the entry of a new treatment…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for Follicular Lymphoma Treatment
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China-based biotechnology leader BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for its BTK inhibitor Brukinsa (zanubrutinib) as a treatment for relapsed/refractory follicular lymphoma (r/r FL). This recommendation positions Brukinsa as…
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Eli Lilly’s Tirzepatide Shows Robust Weight Loss Results in Phase III Study
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Eli Lilly (NYSE: LLY) has released compelling efficacy results from a Phase III study evaluating its GLP-1 receptor agonist, tirzepatide, in adults with obesity or overweight accompanied by comorbidities, excluding type 2 diabetes (T2D). The study successfully met its two co-primary endpoints, demonstrating superiority over placebo in weight loss after…
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Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
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China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular…
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Abbisko Therapeutics to Unveil Phase I Data for ABSK011 and ABSK043 at ESMO 2023
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Shanghai-based biotech powerhouse Abbisko Therapeutics Co., Ltd (HKG: 2256) is preparing to present the results of Phase I clinical studies for two of its pipeline candidates at the 2023 European Society for Medical Oncology (ESMO) Congress. The spotlight will be on ABSK011, a small-molecule FGFR4 inhibitor, and ABSK043, an in-house…
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CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug Application (NDA) for its maralixibat (CAN108) has been accepted for review by the National Medical Products Administration (NMPA) in China, with the added benefit of priority review status. This marks a significant step forward in…
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Fosun Pharma Initiates Phase III Trial for ET-26 Anesthetic in China
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced the commencement of a Phase III clinical study for its drug ET-26 (methoxyethyl etomidate). This marks a significant milestone in the development of new anesthetic solutions, with ET-26 being evaluated as an induction therapy…
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Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
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China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind, placebo-controlled Phase I/II study. The study will assess the efficacy and safety of its innovative product VUM02, a…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
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Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
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China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
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Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
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China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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Roche’s Ocrevus Demonstrates Long-Term Efficacy in Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has presented compelling long-term efficacy data for its selective immunosuppressant Ocrevus (ocrelizumab) in the treatment of multiple sclerosis (MS). The 10-year results from a Phase III extension study provide significant insights into the drug’s sustained impact on patients with relapsing and primary progressive forms…
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Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HYP2090PTSA. This small molecule KRAS G12C/PI3K inhibitor is intended for the treatment of advanced solid tumors with KRAS G12C…
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AbbVie’s Rinvoq Demonstrates Sustained Efficacy in Late-Stage Atopic Dermatitis Study
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AbbVie (NYSE: ABBV) has announced late-stage results for its JAK inhibitor Rinvoq (upadacitinib) in the treatment of moderate-to-severe atopic dermatitis, a skin condition characterized by inflammation and itching. The data, released this week, highlights the drug’s performance over an extended period of two years. Sustained Efficacy in Atopic DermatitisThe primary…
