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Mabwell’s 6MW3511 Accepted by NMPA for Advanced Solid Tumor Treatment
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that a clinical trial filing for its 6MW3511 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company’s innovative oncology pipeline. Drug Mechanism and Innovation6MW3511 is a bifunctional protein linking an…
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Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
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Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug Application (NDA) filing for its Obizur (susoctocog alfa) has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for use as an on-demand treatment and prevention of bleeding in…
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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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Yabao Pharmaceutical’s YBSW015 Gets Australian Ethical Approval for COVID-19 Trial
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received clinical trial ethical approval in Australia to conduct a Phase I clinical study for its YBSW015, a bispecific neutralizing antibody against SARS-CoV-2 developed to treat COVID-19 infection. Mechanism of ActionYBSW015 is a bispecific antibody (BsAb) targeting…
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Suzhou Zelgen’s JAK Inhibitor Jacktinib Gets NMPA Green Light for COVID-19 Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 Janus kinase (JAK) inhibitor, jacktinib, in patients with severe COVID-19. Mechanism of ActionJacktinib works by blocking the signal transducer…
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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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Jiangsu Hengrui Medicine’s SHR4640 Receives NMPA Approval for Gout Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative gout drug SHR4640. The study will evaluate the drug in combination with febuxostat for hyperuricemia in gout patients. Drug MechanismSHR4640 is…
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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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Walvax Biotechnology Halts EV71 Vaccine Development Amid Changing Disease Trends
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the decision to terminate a clinical study and end development for its recombinant enterovirus 71 (EV71) virus vaccine (Pichia pastoris). The company’s press release states that the recombinant EV71 vaccine, which first entered clinical trials in China in June 2019, was…
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Jiangsu Hengrui Medicine’s Hetrombopag Olamine Receives FDA Orphan Drug Designation for ITP
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan drug designation (ODD) status from the US FDA for its hetrombopag olamine as a treatment for primary immune thrombocytopenia (ITP). The drug was approved in China in June 2021 for the treatment of ITP in…
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Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG). Understanding Myasthenia GravisMyasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve…
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Bristol-Myers Squibb Launches Reblozyl in China for β-Thalassemia Treatment
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US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the commercial launch of its first-in-class erythrocyte maturation agent, Reblozyl (luspatercept), in China. The product, filed by its subsidiary Celgene, received approval in China in January 2022 for the treatment of adult β-thalassemia patients who require regular red blood cell…
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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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Changchun High & New Technology’s Jinnamab Approved for AOSD Clinical Study by US FDA
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) has announced that it has received approval from the US FDA to conduct a clinical study for its jinnamab in adult-onset still disease (AOSD). Understanding AOSDAOSD, originally referring to the systemic onset of juvenile chronic arthritis, can also occur…
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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…
