The pharma news review of this week totally covers 22 pieces of news in 3 sections, including drug review, R&D, and business.
NMPA
Marketing Application
1. On April 20, Hengrui Medicine announced the filing of a marketing application for irinotecan hydrochloride liposome injection, together with 5-FU/LV for the second-line treatment of locally advanced or metastatic pancreatic cancer after failure of treatment with gemcitabine. This product is a new preparation developed by Hengrui based on the existing commercially available Irinotecan Hydrochloride Injection and its lyophilized powder injection, which can be targeted to the tumor by changing the formulation.
Approval
2. On April 18, KingstronBio announced that its in-house R&D cardiac surgical biological patch Elite Air was approved for marketing for the repair of ventricular septal defects in cardiac surgery. Kings Bio's Elite Air is a bovine pericardium patch processed by dehydration technique.
3. On April 21, the latest approval from NMPA showed that a teriparatide injection from Salubris was approved for marketing. Teriparatide is a 34-amino acid recombinant human parathyroid hormone (PTH) analog, the original manufacturer of which is Eli Lilly. It was approved for marketing in China in 2011 and in October 2019, Salubris’s recombinant teriparatide for injection was first approved for marketing to treat postmenopausal osteoporosis.
4. On April 21, the NMPA official website announced that the procarbazine hydrochloride capsule declared by Zhaoke Pharmaceutical, the subsidiary of Lee's Pharm, was approved for marketing to treat Advanced Hodgkin's lymphoma. The procarbazine hydrochloride capsule is an alkylating agent and a cycle non-specific antineoplastic drug.
Clinical Trials
Application
5. On April 18, CDE's official website revealed that Qilu Pharmaceutical's clinical application for a new and improved class 2.2 drug, oseltamivir phosphate oral soluble film, was accepted. The original manufacturer of oseltamivir is Roche, while in China, Qilu Pharmaceutical has become the first enterprise to develop the oseltamivir oral soluble film. Currently, various dosage forms of oseltamivir are under development in China, including orally disintegrating tablets, sustained/controlled release formulation, capsule, granule, suspension, etc.
6. On April 20, the CDE official website revealed that a new clinical trial application of Daiichi Sankyo's U3-1402 was submitted. U3-1402 is an ADC drug that targets HER-3. It started a Phase II clinical trial for EGFR mutation non-small cell lung cancer (NSCLC) in November 2021. Longside Daiichi Sankyo, Baili Pharmaceutical holds relatively more projects on HER-3 among the few enterprises that are laying out HER-3 targets in China.
7. On April 21, CDE's official website announced that Blueprint Medicines and Zai Lab jointly submitted a clinical trial application for BLU-945 capsules. BLU-945, a highly selective and strong EGFR-TKI developed by Blueprint Medicines, can inhibit the activity of EGFR with double or triple mutations. Zai Lab has the development and exclusive commercialization authority in Greater China.
Approval
8. On April 18, Beihai Biotech published the news that NMPA has approved them to carry out a Phase II clinical research in which BH011 injection treats moderate and high-risk non-muscle-invasive bladder cancer through bladder perfusion. BH011 injection is an innovative variety of docetaxel that can be dosed[RH1] by bladder perfusion, developed by Beihai Biotech.
9. On April 18, 3D Medicines announced the approval of its multi-center, open-label Phase 1b/2 clinical trial application for 3D229 injection in combination with either envafolimab monoclonal antibody injection or lenvatinib for the treatment of advanced solid tumors. 3D229 is an introduced GAS6/AXL inhibitor that has been granted Fast Track by FDA for the indication of platinum-resistant recurrent ovarian cancer.
10. On April 19, the CDE official website revealed that the first-in-class MK-6024 injection applicated by MSD was approved for clinical in China. The proposed indication of MK-6024 is Non-alcoholic steatohepatitis (NASH). As a once-a-week GLP-1R/GCGR dual agonist, MK-6024 is currently in Phase II clinical trials worldwide.
11. On April 20, CDE revealed that Gloria Pharmaceuticals' LA...
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