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BeiGene Presents Groundbreaking Clinical Data at ASCO Annual Meeting
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced the presentation of new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data highlights the range of BeiGene’s research expertise and the productivity of one of the industry’s largest research and development teams. The…
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Chia Tai Tianqing’s TQ-B3525 Heads for Priority Review for Recurrent Follicular Lymphoma
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The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQ-B3525, a phosphatidylinositol 3-kinase (PI3-K) α/δ inhibitor, is set to receive priority review status for the treatment of recurrent/refractory follicular lymphoma (FL) as a third-line or later treatment option. TQ-B3525: A Dual Inhibitor Addressing Drug ResistanceTQ-B3525 is…
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Sanofi Launches Soliqua for Type 2 Diabetes Treatment in China
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced the official market launch of Soliqua (insulin glargine, lixisenatide) in China, targeting adults with type 2 diabetes (T2DM) who struggle with poor blood glucose control. This product can be integrated with other oral hypoglycemic drugs, along with diet and exercise, to enhance…
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GenScript’s Legend Biotech Files Type II Variation Application for Carvykti with EMA
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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), has submitted a Type II variation application to the European Medicines Agency (EMA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The application is supported…
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Takeda and HutchMed’s Fruquintinib Receives Priority Review Status from FDA
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Takeda (TYO: 4502) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) have provided an update on the New Drug Application (NDA) filing for Elunate (fruquintinib) with the US FDA. The FDA has granted the filing priority review status and set a Prescription Drug User Fee Act (PDUFA) date for November…
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Sichuan Kelun Pharmaceutical to Present Clinical Data on RET Inhibitor and ADC at ASCO
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has unveiled plans to present clinical trial data for two of its drugs at the upcoming American Society of Clinical Oncology (ASCO) annual meeting. The company will showcase a Phase I clinical trial for its RET inhibitor, KL590586, in…
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BioRay Pharmaceutical’s LIV-1 Targeted ADC BRY812 Files IND in China
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Shanghai-based BioRay Pharmaceutical Co., Ltd has announced that an investigational new drug (IND) filing has been submitted in China for its pipeline antibody drug conjugate (ADC), BRY812. The National Medical Products Administration (NMPA) has accepted the filing, marking a step forward in the potential approval of the LIV-1-targeted ADC for…
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Accropeutics Receives HREC Approval for AC-201 Phase I Trial
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Suzhou-based Accro Bioscience (Suzhou) Limited (Accropeutics) has announced that it has received approval from the Australian Human Research Ethics Committee (HREC) to initiate a Phase I trial for its TYK2/JAK1 inhibitor pipeline candidate, AC-201. The study, which is randomized, double-blind, placebo-controlled, and involves single and multiple ascending doses, aims to…
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Vcanbio Initiates Phase II Clinical Study for Dental Pulp Stem Cell Injection in Periodontitis
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced the imminent initiation of a Phase II clinical study for its innovative human dental pulp mesenchymal stem cell injection, developed to treat chronic periodontitis. This therapy is currently the first of its kind globally, marking a significant advancement…
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Mabwell Bioscience’s 9MW3811 Receives NMPA Approval for Clinical Trials in Oncology and Fibrosis
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed IL-11 monoclonal antibody (mAb), 9MW3811. The drug is intended for the treatment of various advanced malignant tumors and fibrotic diseases. Therapeutic Potential…
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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…
