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Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
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Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 and GIP receptors and is being developed for the treatment of type 2…
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Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
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China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
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Sanofi’s Amlitelimab Shows Promising Phase IIb Results in Atopic Dermatitis, Potential for 12-Week Dosing
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Sanofi (NASDAQ: SNY) announced this week promising results from a Phase IIb study of its OX40-ligand blocker, amlitelimab, in patients with moderate to severe atopic dermatitis. The study focused on participants who demonstrated a favorable response after an initial 24-week treatment period. Following a subsequent 28-week maintenance or withdrawal phase,…
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Jiangsu QYuns Therapeutics Eyes HK IPO to Raise Up to HKD 243 Million for Autoimmune Pipeline
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Jiangsu QYuns Therapeutics Co., Ltd. (HKG: 2509), based in China, is poised to launch an initial public offering (IPO) of 12,046,400 shares on the Hong Kong Stock Exchange, with a pricing range set between HKD 19.8 and HKD 20.2 per share. The company anticipates raising between HKD 239 million and…
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Legend Biotech Reports Q4 and Full-Year 2023 Financials with Focus on Carvykti Milestones
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Legend Biotech Corporation (NASDAQ: LEGN) has released its financial results for the fourth quarter and full year of 2023, along with key business highlights. The company reported licensing income of USD 35.2 million and cooperation income of USD 249.8 million, primarily attributed to milestone payments related to the Carvykti (ciltacabtagene…
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Gilead Nears Completion of CymaBay Acquisition After Waiting Period Expires
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Gilead Sciences (NASDAQ: GILD) has moved one step closer to finalizing its cash tender offer for the acquisition of fellow US company CymaBay Therapeutics (NASDAQ: CBAY), following the expiration of a mandatory waiting period under local laws last week. The two companies had previously submitted regulatory filings for approval of…
