With the second week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 6 sections: approval, R&D, policies, transactions, listing and miscellany that happened during July 6-10, including 21 pieces.
R&D
8. Novartis’ MBG453, an anti-TIM-3 monoclonal antibody, was approved for a clinical trial in China on July 6 to treat patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R or chronic myelomonocytic leukemia-2 (CMML-2) in combination with azacitidine.
9. The clinical trial application filed by Sanofi/Bioverativ in China for the recombinant human coagulation factor VIII Fc-von Willebrand factor-XTEN fusion protein (BIVV001) for injection was accepted by the CDE on July 6. BIVV001 is a novel recombinant factor VIII therapy used to treat severe hemophilia type A.
10. Beijing Immunochina Pharmaceuticals announced on July 7 that a phase I clinical trial of treating relapsed/refractory non-Hodgkin lymphoma with IM19 would soon be conducted to evaluate the safety and preliminary effectiveness of IM19. As an anti-CD19 chimeric antigen receptor T-cell injection, M19 received the NMPA’s clinical trial approval in Apr. 2020.
11. A phase 1 clinical trial was initiated for Betta Pharmaceuticals’ Class 1 new drug: MRX2843 tablets on July 7 to treat advanced solid tumors. As a novel, potent, orally bioavailable, small-molecule inhibitor, MRX2843 is a Mer tyrosine kinase (MerTK) and FMS-like tyrosine kinase 3 (FLT3) inhibitor with a brand-new chemical structure.
12. Kelun Pharmaceutical initiated the phase II clinical trial of its Class 1 new drug: KL280006 injection on July 8 to treat acute pain. KL280006 injection is a selective peripheral κ-opioid receptor agonist developed by Kelun with independent intellectual property, being an opioid analgesic.
13. Aosaikang announced on July 8 that “ASKB589 Injection”, a new antitumor biological drug developed by it with independent intellectual property, was approved for a clinical trial to treat malignant solid tumors such as CLND18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, and pancreatic cancer.
14. HEC’s clinical trial application for recombinant humanized anti-VEGF monoclonal antibody for injection was accepted by the CDE on July 9, which is a bevacizumab biosimilar. The original bevacizumab of Roche was approved in China in 2010.
15. JS InnoPharm announced on July 10 that the phase I clinical trial of JSI-1187 in the U.S. completed dosing its first patient. JSI-1187 is an oral, highly selective ERK1/2 kinase inhibitor mainly developed to treat tumors with MAPK pathway mutations.
8. Novartis’ MBG453, an anti-TIM-3 monoclonal antibody, was approved for a clinical trial in China on July 6 to treat patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R or chronic myelomonocytic leukemia-2 (CMML-2) in combination with azacitidine.
9. The clinical trial application filed by Sanofi/Bioverativ in China for the recombinant human coagulation factor VIII Fc-von Willebrand factor-XTEN fusion protein (BIVV001) for injection was accepted by the CDE on July 6. BIVV001 is a novel recombinant factor VIII therapy used to treat severe hemophilia type A.
10. Beijing Immunochina Pharmaceuticals announced on July 7 that a phase I clinical trial of treating relapsed/refractory non-Hodgkin lymphoma with IM19 would soon be conducted to evaluate the safety and preliminary effectiveness of IM19. As an anti-CD19 chimeric antigen receptor T-cell injection, M19 received the NMPA’s clinical trial approval in Apr. 2020.
11. A phase 1 clinical trial was initiated for Betta Pharmaceuticals’ Class 1 new drug: MRX2843 tablets on July 7 to treat advanced solid tumors. As a novel, potent, orally bioavailable, small-molecule inhibitor, MRX2843 is a Mer tyrosine kinase (MerTK) and FMS-like tyrosine kinase 3 (FLT3) inhibitor with a brand-new chemical structure.
12. Kelun Pharmaceutical initiated the phase II clinical trial of its Class 1 new drug: KL280006 injection on July 8 to treat acute pain. KL280006 injection is a selective peripheral κ-opioid receptor agonist developed by Kelun with independent intellectual property, being an opioid analgesic.
13. Aosaikang announced on July 8 that “ASKB589 Injection”, a new antitumor biological drug developed by it with independent intellectual property, was approved for a clinical trial to treat malignant solid tumors such as CLND18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, and pancreatic cancer.
14. HEC’s clinical trial application for recombinant humanized anti-VEGF monoclonal antibody for injection was accepted by the CDE on July 9, which is a bevacizumab biosimilar. The original bevacizumab of Roche was approved in China in 2010.
15. JS InnoPharm announced on July 10 that the phase I clinical trial of JSI-1187 in the U.S. completed dosing its first patient. JSI-1187 is an oral, highly selective ERK1/2 kinase inhibitor mainly developed to treat tumors with MAPK pathway mutations.
Related News:
Pharmaceutical News of the Week (June. 29th-July. 3rd) | PharmaSources.com - Updates on Policies,Transactions and Others
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