This week, the release of Phase III clinical data for treating outpatients infected with mild and moderate COVID-19 with Kintor Pharmaceuticals' proxalutamide sparked an intense interest. The pharma news review of this week covers a total of 18 pieces of news in 3 sections, including review approval, R&D, and business.
Review approval
NMPA
Marketing Application
1. On April 7, the CDE official website revealed that the marketing application for Erenumab, developed by Novartis in collaboration with Amgen, was submitted and accepted. This is the first anti-CGRPR monoclonal antibody to be declared for marketing in China. Erenumab (AMG334), first developed by Amgen, is a fully human IgG2 monoclonal antibody that treats migraine by binding to and antagonizing CGRP receptor function.
2. On April 7, the CDE official website revealed that the marketing application for imported new drug safinamide tablets has been submitted and accepted. Safinamide is a highly selective and reversible third-generation monoamine oxidase B (MAO-B) inhibitor jointly developed by Zambon and Newron for the treatment of Parkinson's disease.
Approval
3. On April 6, according to NMPA's latest approval documents, Innovent's pemigatinib tablets were approved for marketing. It is for the treatment of adult patients with advanced/metastatic or non-surgically resectable cholangiocarcinoma who have received at least one prior systemic therapy and whose presence of FGFR2 fusion or rearrangement has been confirmed by testing. Pemigatinib tablets were developed by Incyte, and Innovent acquired its commercialization right in Greater China in December 2018.
4. On April 6, NMPA’s official website revealed that AbbVie's upadacitinib sustained release tablets were approved for marketing. It is for the treatment of adult patients with active psoriatic arthritis (PsA) who are not efficacious or intolerant to one or more DMARDs. This is the third indication following the approval of the product in China for the treatment of moderate-to-severe active rheumatoid arthritis and moderate-to-severe atopic dermatitis.
Clinical Application
5. On April 1, the CDE official website revealed that Pfizer's PREVNAR 20 was accepted for clinical application. The product was approved for marketing by FDA in June 2021 for vaccination of adults aged 18 years and older to prevent invasive diseases and pneumonia caused by 20 serotypes of streptococcus pneumonia (pneumococcus). PREVNAR 20 is an upgraded version of Pfizer's PREVNAR 13.
6. On April 7, CDE’s official website revealed that the clinical application for PEN-866 for injection was accepted. PEN-866 is the small molecule drug conjugate (SMDC) developed by SciClone Pharmaceuticals and is now in a Phase II basket trial for solid tumors in the U.S. Originally developed by Tarveda, PEN-866 was exclusively licensed by SciClone Pharmaceuticals in Greater China in March 2020.
Approval
7. On April 3, CSPC Pharmaceutical Group announced that it has received clinical research approval for SYS6006, an mRNA vaccine developed by CSPC Pharmaceutical Group against the mutated COVID-19 strains. The product is designed with targeted antigenic mutations based on the prevalence of the strains. The preclinical research has shown that the product provides good immune protection against the current mainstream mutant strains, including Omicron and Delta.
8. On April 7, Kelun Pharmaceutical announced the clinical approval of SKB264 for the treatment of patients with advanced or metastatic Triple Negative Breast Cancer (TNBC) who have failed at least second-line treatment. This randomized controlled trial (RCT) will serve as a registered Phase III clinical trial in support of the marketing application. SKB264 is a TROP2-ADC for which Kelun Pharmaceutical has independent intellectual property rights and is the first national TROP2-ADC to receive IND approval.
Breakthrough therapy
9. On April 6, the CDE official website revealed that Innovent's IBI310, an anti-CTLA-4 monoclonal antibody (mAb), combined with PD-1 monoclonal antibody Sintilimab is proposed to be in...
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