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Innovent Biologics’ Tyvyt Approved for First-Line Esophageal Squamous Cell Carcinoma
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The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801) has received approval for a new indication of its PD-1 inhibitor Tyvyt (sintilimab) for the treatment of first-line esophageal squamous cell carcinoma (ESCC). This marks the fifth indication approval for the drug in China. Drug…
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Iomics Biosciences Secures RMB 100 Million for Proteomics and Spatialomics Expansion
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Beijing-based Iomics Biosciences Co., Ltd, a developer of gene sequencing and diagnostic equipment, has reportedly secured close to RMB 100 million (USD 14.96 million) in a Series A financing round co-led by Oriza Seed and Apricot Capital. The proceeds will be directed toward advancing technology platforms in proteomics and spatialomics,…
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InnoCare and Keymed Biosciences’ CCR8-Targeted mAb CM369 Accepted by NMPA
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China-based InnoCare (HKG: 9969) and Keymed Biosciences Inc. (HKG: 2162) announced that an Investigational New Drug (IND) filing for CM369, a monoclonal antibody targeting C-C chemokine receptor 8 (CCR8), has been accepted for review by the National Medical Products Administration (NMPA). This potential first-in-class drug is designed to enhance tumor-targeted…
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Cellular Biomedicine Group’s C-CAR039 Receives NMPA Approval for B-Cell NHL Study
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China-based Cellular Biomedicine Group Inc. (CBMG), a private company following a merger deal in February last year, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study of its chimeric antigen receptor (CAR)-T cell therapy C-CAR039 in patients with relapsed or refractory…
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Sirnaomics’ STP705 Shows Promising Results in Skin Cancer Trial
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate, STP705, for the treatment of skin cancer, in the May 2022 issue of the Journal of Drugs in Dermatology (the “JDD”). Clinical Trial ResultsThe single-center, open-label, dose-escalation…
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Sichuan Kelun’s KL340399 Wins NMPA Approval for Solid Tumor Trials
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection. Drug Mechanism…
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Beijing Aosaikang’s ASKG315 Receives NMPA Approval for Solid Tumor Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced that its clinical trial application for ASKG315, an in-house developed recombinant human interleukin-15 prodrug Fc fusion protein, has been accepted by China’s National Medical Products Administration (NMPA). This marks a significant milestone for the company’s oncology pipeline. Drug Mechanism and InnovationASKG315 is…
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Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment…
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Alphamab Oncology Doses First Patient in Phase I Trial for PD-L1/OX40 Bispecific Antibody KN052
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China-based Alphamab Oncology (HKG: 9966) has announced the dosing of the first patient in a Phase I clinical trial in China (KN052-CHN-001) for its pipeline candidate KN052. This bispecific antibody (BsAb) targets programmed-death ligand 1 (PD-L1) and OX40 and is being evaluated as a treatment for general advanced solid tumors.…
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Clover Biopharmaceuticals Initiates SCB-219M Clinical Study for CIT Treatment
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the first subject dosing in a Phase I clinical study for its in-house developed thrombopoietin receptor agonist, SCB-219M. This multi-center, dosage escalation and expansion study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of SCB-219M in CIT patients. Interim safety…
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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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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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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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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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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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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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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
