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The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib) is likely to receive priority review status for the treatment of children with NTRK fusion positive locally advanced or metastatic solid tumors. This priority review status is justified by the drug’s eligibility for conditional approval.…
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that it will publish the results of a Phase I clinical study at the American Society of Clinical Oncology (ASCO) annual meeting. The study combines Asieris’ APL-1202 with BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab as…
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China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody drug conjugate (ADC), ATG-022, targeting Claudin 18.2, has been granted two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. This brings the…
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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy. HX009’s Clinical…
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China-based Clover Biopharmaceuticals Ltd (Clover; HKG: 2197) has announced the establishment of a commercial partnership with Keyuan Xinhai (Beijing) Medical Products Trading Co., Ltd (Kyuan Trade). The strategic alliance aims to prepare for the commercial launch of AdimFlu-S (QIS), the only imported quadrivalent seasonal influenza vaccine approved for use in…
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China-based Minghui Pharmaceutical Inc. has announced the commencement of a first-in-human Phase Ia trial for its pipeline candidate, MHB018A. This novel fusion protein combines a humanized single domain IGF-1R antibody with a human Fc fragment, and the study aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers. MHB018A: A…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as…
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Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has attained market approval from the National Medical Products Administration (NMPA) for its CMAB007, a biosimilar version of Roche/Genentech’s anti-IgE dermatology and asthma therapy omalizumab (trade name: Xolair). This approval marks the first home-grown therapeutic biologic…
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Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been officially launched in the Chinese market. The drug received marketing approval in China in February 2023 and is now available for the treatment of unresectable or metastatic HER2 positive…
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or…
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The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic…
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China-based 3SBio Inc. (HKG: 1530) has announced the enrollment of the first patient in a Phase III clinical study for its thrombopoietin, which is being assessed for the treatment of thrombocytopenia in patients with chronic liver disease who are planned for invasive surgery. Background of 3SBio’s Thrombopoietin (TPIAO)Developed in-house, 3SBio’s…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities have accepted for review another indication approval filing for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with paclitaxel (albumin bound) for the treatment of PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic…
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US-based Oculis Holding AG (NASDAQ: OCS) has announced positive top-line results from Stage 1 of its Phase III DIAMOND trial for the eye drop drug candidate OCS-01, which is being assessed as a treatment for diabetic macular edema (DME). The trial data indicate that the drug achieved its primary efficacy…
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Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681) has announced that the National Medical Products Administration (NMPA) has accepted for review an investigational new drug (IND) filing for SM17, a potential global first-in-class monoclonal antibody. Developed in-house by SinoMab, SM17 is the world’s first humanized IgG4-κ monoclonal antibody targeting IL-17RB,…
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China-based HighTide Therapeutics Inc. (HKG: 2511) has announced that its Phase II study for the drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) as a treatment for type 2 diabetes (T2DM) has achieved its primary endpoint and several important secondary endpoints. The study demonstrated that treatment with HTD1801 resulted in a superior…
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Zhejiang Conba Pharmaceutical Co., Ltd (SHA: 600572) has announced that its modified version of US firm Marnac’s pirfenidone, in the form of an inhalable solution, has been approved for clinical trials in China. The drug is aimed at treating idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by diffuse…
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has separately announced clinical trial approvals from the National Medical Product Administration (NMPA) for two of its drug candidates, SHR-1654 and SHR-2001. These molecules are set for assessment as potential treatments for rheumatoid arthritis and systemic lupus erythematosus, respectively. SHR-1654: A Novel Treatment for…
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Sino-US Laekna has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its LAE102 antibody. The drug is set to be assessed as a potential treatment for non-small cell lung cancer (NSCLC). This achievement marks LAE102 as Laekna’s first internally-discovered drug candidate…
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US-based Cabaletta Bio, Inc. (NASDAQ: CABA) has announced that the US Food and Drug Administration (FDA) has cleared the company’s second Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. The clearance is for a Phase I/II study in patients with active idiopathic…