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BeiGene’s Brukinsa Faces Three-Month FDA Approval Delay for CLL/SLL Indication
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China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The US Food and Drug Administration (FDA) has pushed back the…
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Junshi Biosciences Receives NMPA Approval for Fourth-Generation EGFR Inhibitor WJ13404
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Shanghai-based biotech Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for WJ13404, a fourth-generation EGFR inhibitor developed in collaboration with Wigen Biomedicine. This approval positions Junshi Biosciences at the forefront of advanced non-small cell lung cancer (NSCLC)…
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Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for its Bevagen (bevacizumab), a biosimilar version of Avastin. This approval marks a significant milestone for Innovent as it expands its market presence in Southeast Asia. Approved IndicationsInnovent’s bevacizumab has been…
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Innovent Biologics’ IBI306 Accepted for Review by China’s NMPA for Hypercholesterolemia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that a New Drug Application (NDA) filing for its recombinant fully human anti-PCSK-9 monoclonal antibody (mAb) IBI306 has been accepted for review by the National Medical Products Administration (NMPA). The application covers the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial…
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Clover Biopharmaceuticals Begins Phase III Trial for COVID-19 Booster SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the immunization of the first group of patients in a double-blind, randomized, controlled Phase III clinical study. The trial is assessing the safety and immunogenicity of its COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) as a booster shot. Participants previously received two doses…
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InventisBio’s KRAS G12C Inhibitor D-1553 Earns CDE Breakthrough Therapy Status
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China-based InventisBio (Shanghai) Co., Ltd announced receiving breakthrough therapy designation (BTD) status for its KRAS G12C inhibitor D-1553 from the Center for Drug Evaluation (CDE), marking the first such recognition in China. Drug Profile and Clinical TrialsD-1553 is a highly efficient and selective KRAS G12C inhibitor undergoing a global multi-center…
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CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a Phase I single-dose escalation study for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The results were unveiled at the European Hematology Association (EHA) congress in Singapore.…
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Zai Lab’s Repotrectinib Earns Two Breakthrough Therapy Designations in China for ROS1+ NSCLC
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China-based biopharma Zai Lab Ltd (NASDAQ: ZLAB) announced receiving two breakthrough therapy designations (BTDs) from the Center for Drug Evaluation (CDE) for its repotrectinib based on positive Phase I/II TRIDENT-1 study results. The designations cover ROS1 positive metastatic non-small cell lung cancer (NSCLC) patients previously treated with one frontline ROS1…
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OnCusp Therapeutics Licenses Multitude’s CDH6 ADC for Global Development
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US-based OnCusp Therapeutics has entered into a licensing agreement with China’s Multitude Therapeutics for the global development and commercialization of AMT-707 (CUSP06), a preclinical-stage cadherin-6 (CDH6) antibody-drug conjugate (ADC). OnCusp gains exclusive rights outside Greater China, while Multitude receives undisclosed upfront, milestone payments, and royalties. Scientific Rationale and Drug ProfileCDH6…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the publication of Phase I clinical study results for its Bcl-2 inhibitor lisaftoclax (APG-2575) in Chinese patients with recurrent/refractory non-Hodgkin lymphoma (r/r NHLs). The results are being released at the European Hematology Association (EHA) congress 2022 meeting. Clinical Trial ResultsThe results demonstrated that APG-2575…
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Kangpu Biopharmaceuticals Begins Phase IIa Trial of KPG-818 for Systemic Lupus Erythematosus
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Shanghai-based Kangpu Biopharmaceuticals, Ltd has announced the first patient dosing in a multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical study. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KPG-818, an orally bioavailable NeoMIDES molecular glue, in patients with systemic lupus erythematosus (SLE). Mechanism and DevelopmentKPG-818…
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Shanghai MicroPort MedBot Completes World’s Furthest Remote Robot Surgery via 5G
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced the successful completion of a remote surgery performed by the Toumai endoscopic surgery robot via 5G connection between Jiangsu Province Hospital and Xinjiang Kezhou Ren Min Yiyuan. This achievement marks the world’s furthest remote robot surgery conducted to date. Toumai Robot’s…
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Pfizer’s Lorbrena Receives First Prescription in China for NSCLC Treatment
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US pharmaceutical giant Pfizer Inc. (NYSE: PFE) has announced the first prescription of its third-generation ALK inhibitor Lorbrena (lorlatinib) in Guangdong province, China. This milestone marks the official market launch of the drug for Chinese non-small cell lung cancer (NSCLC) patients, following its approval two months prior. Drug Profile and…
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HealZen Therapeutics and Hisun Partner on First-in-Class Protein Degradation Product
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Hangzhou-based HealZen Therapeutics Protein Degradation Hisun Pharmaceutical Co., Ltd. a has formed a strategic partnership with compatriot firm Zhejiang Hisun Pharmaceutical Co., Ltd. to jointly develop a first-in-class protein degradation product. The collaboration involves shared research and development (R&D) efforts, with Hisun obtaining exclusive global development and commercialization rights. Hertz…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the publication of Phase I clinical study results for its Bcl-2 inhibitor lisaftoclax (APG-2575) in Chinese patients with recurrent / refractory non-Hodgkin lymphoma (r/r NHLs) at the European Hematology Association (EHA) congress 2022. Clinical Trial ResultsThe results demonstrated that APG-2575 was well tolerated at…
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Pfizer’s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis
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The Center for Drug Evaluation (CDE) website indicates that Pfizer’s (NYSE: PFE) category 1 drug ritlecitinib (PF-06651600) has obtained breakthrough therapy designation (BTD) status for use in moderate to severe active ulcerative colitis (UC) in adults. Mechanism of ActionRitlecitinib, a Janus kinase 3 (JAK3) inhibitor, selectively inhibits JAK isoenzymes through…
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Ascletis Pharma Appoints John P. Gargiulo as Chief Business Officer to Lead Growth
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the appointment of Mr. John P. Gargiulo as its new Chief Business Officer (CBO). Formerly the North America President and CEO for Daiichi Sankyo, Gargiulo will lead Ascletis’s corporate business development and alliance management, reporting to Dr. Jinzi J. Wu, PhD, founder,…
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Beijing Winsunny Pharma Plans IPO to Boost Drug Development and Production
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China-based Beijing Winsunny Pharmaceutical Co., Ltd. has announced plans for an initial public offering (IPO) of 120 million shares on the Shanghai Stock Exchange. The proceeds, totaling RMB 1.74 billion (USD 258 million), will fund the Phase I industrialization project, research and development of novel and generic drugs, and working…
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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
