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Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
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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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Asieris Pharmaceuticals to Present Phase I Results of APL-1202 Combo at ASCO
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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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Antengene’s ATG-022 Earns FDA Orphan Drug Designations for Gastric and Pancreatic Cancers
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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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Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
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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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Clover Biopharmaceuticals Partners with Kyuan Trade for Commercial Launch of AdimFlu-S (QIS) in China
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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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Minghui Pharmaceutical Initiates First-in-Human Trial for IGF-1R Antibody Fusion Protein MHB018A
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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’s TQ-B3525 Files for Market Approval with CDE
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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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MabPharm’s CMAB007 Receives NMPA Approval for IgE-Mediated Asthma Treatment
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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, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
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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’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
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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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Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
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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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3SBio Inc. Initiates Phase III Clinical Study for Thrombopoietin in Chronic Liver Disease Patients
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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’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
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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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Oculis’ OCS-01 Achieves Primary Efficacy Endpoint in Phase III DIAMOND Trial for DME
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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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SinoMab BioScience’s SM17 IND Accepted by NMPA for Potential Global First-in-Class Monoclonal Antibody
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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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HighTide Therapeutics’ HTD1801 Meets Primary and Secondary Endpoints in Type 2 Diabetes Phase II Study
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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’s Inhalable Pirfenidone for IPF Clears for Chinese Clinical Trials
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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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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Two Autoimmune Disease Drug Candidates
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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 Receives FDA Clearance for LAE102 Clinical Trial in NSCLC
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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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Cabaletta Bio’s CABA-201 Clears FDA for Phase I/II Study in Idiopathic Inflammatory Myopathy
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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…
