drug research and development progress
1. Roche’s CD20/CD3 dual antibody Lunsumio was approved by the FDA for marketing
On December 22, Roche announced that the U.S. FDA has approved the listing of its CD20/CD3 dual antibody Lunsumio for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more systemic therapies.
2. Gilead HIV drug Sunlenca was approved by the FDA
On December 22, Gilead announced that the FDA approved the long-acting capsid inhibitor Sunlenca in combination with other antiretroviral drugs (ARVs) for the treatment of severely treatment-experienced adults with multidrug-resistant HIV-1 infection.
3. Reco Biotech’s ReCOV is more effective than Pfizer’s mRNA vaccine against BF.7 and other major epidemic strains
On December 23, Reco Biotech announced It was announced that the phase II sequential boosting clinical trial of the recombinant coronavirus vaccine ReCOV has achieved positive results. The neutralizing antibody levels induced by the sequential boosting of ReCOV against the Omicron variant strains BF.7 and BA.2.75 were significantly better than those of the mRNA vaccine.
4. Antengene has submitted a marketing application for selinesol tablets in Macau, Malaysia and Thailand.
On December 23, Antengene announced that it has submitted a new drug marketing application for the XPO1 inhibitor selinesol tablets in Macau, Malaysia and Thailand, which is intended to be used to treat relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma.
5. The anti-OX40 monoclonal antibody introduced by Amgen was applied for clinical trials in China
On December 23, the official website of the Center for Drug Evaluation of the China State Food and Drug Administration (CDE) announced that Amgen applied for a clinical trial application for the Class 1 new drug AMG 451, and it was accepted. Public information shows that AMG 451 is a potential "first-in-class" fully humanized anti-OX40 monoclonal antibody. Amgen is conducting a phase 3 clinical study of this drug to treat atopic dermatitis . In June 2021, Amgen and Kyowa Kirin announced a cooperation that could reach US$1.25 billion to jointly promote the development of this innovative therapy in multiple inflammatory diseases such as atopic dermatitis.
6. The world's first CD39/TGF-β dual antibody was approved for clinical use
On December 21, ES014 for injection, independently developed by Esview Biotech, was clinically approved by the NMPA for the treatment of solid tumors . In May this year, ES014 was approved by the FDA to conduct clinical trials. ES014 is a bifunctional molecule developed by Kewang Pharmaceuticals that can target both CD39 and TGF-β. It is designed by fusing the extracellular domain of the TGF-β type II receptor to an antibody targeting CD39.
7. CSPC’s anti-TNFR2 antibody has been approved for clinical use in the United States
On December 22, CSPC announced that its new drug clinical trial application for the fully human antibody drug NBL-020 developed by its subsidiary NovaRock Biotherapeutics has been approved by the US FDA and can be used to conduct clinical trials in the United States for the treatment of advanced solid tumors.
Industry News
1. Shanghai Pharmaceuticals becomes the exclusive importer and distributor of Ensitrelvir in mainland China
On December 23, Shanghai Pharmaceuticals announced that , a wholly-owned subsidiary of , signed an agreement with Shionogi for the anti-new coronavirus oral drug Ensitrelvir. Shanghai Pharmaceuticals will serve as the exclusive importer and distributor of Ensitrelvir imported products in mainland China.
2. Merck of Germany introduced two new ADC drugs from Mersana
On December 22, Merck of Germany announced a research cooperation and commercial licensing agreement with Mersana Therapeutics to discover new ADC drugs, using Mersana’s proprietary immune synthetic STING-agonist ADC platform to target up to two targets. The Immunosynthetin platform is designed to generate systemically administered ADCs that locally activate STING signaling in tumor-resident immune cells and tumor cells expressing the antigen , unleashing the anti-tumor potential of innate immune stimulation.
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