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' LAG-3 monoclonal antibody was first approved for clinical trials. It is Gloria’s second new biologic drug to enter clinical development after PD-1 monoclonal antibody zimberelimab. LAG-3 monoclonal antibody is a collaboration between Gloria and WuXi Biologics, and the cooperation between the two companies was first reached in 2015.

12. On April 20, XPH announced that TAEST1901 injection was approved for clinical use and is proposed to be used for the treatment of advanced liver cancer or other advanced tumors with tissue genotype HLA-A*02:01 and positive expression of tumor antigen AFP. This is the second TCR-T product from XLifeSc to receive clinical trial approval, following the TAEST16001 Injection.

13. On April 20, CDE announced that NBTXR3, a Class 2.4 new drug, has obtained an implied license for the clinical trials, proposing to treat head and neck squamous cell carcinoma. NBTXR3 is a novel radiation enhancer developed by Nanobiotix and intended for the treatment of tumors, for which Lianbio has the exclusive license to develop and commercialize the product in Greater China.

14. On April 20, JW Therapeutics announced that the Phase I clinical trial application, in which relmacabtagene autoleucel injection is used to treat recurrent or refractory B cells acute lymphoblastic leukemia (r/r B-ALL) in children and young adults, was approved. Relmacabtagene Autoleucel injection is a CAR-T product targeting CD19 and was approved for marketing in September 2021.

FDA

Clinical Trials

15. On April 18, HAISCO announced the approval of HSK29116's clinical trial application in the United States to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of the drug in subjects with recurrent or refractory B-cell malignant tumors. HSK29116 is the first BTK-PROTAC drug to enter clinical research in China and the second in the world. It is currently undergoing clinical dose-escalation trials in China and Australia.

Marketing

16. On April 19, AstraZeneca and Daiichi Sankyo announced that the new indication marketing application for HER-2ADC drug DS-8201 has been accepted by FDA and granted priority review, with a PDUFA date of 2022Q3. The Indication is for the HER2-mutant unresectable or metastatic NSCLC that has received at least one first-line systemic treatment. It is the first marketing application of DS-8201 in the field of NSCLC.

17. On April 19, Sidansai announced that GCC19 CART had been granted the Fast Track by FDA. GCC19CART, an autologous CAR-T treatment product targeting GCC, was developed by Sidansai Biotechnology as a solid tumor therapy to treat recurrent, refractory, and metastasis colorectal cancer (R/R mCRC). Sidansai plans to initiate a Phase 1 clinical trial of the therapy for R/R mCRC in the United States in mid-2022.

R&D

Publication of Clinical Results

18. On April 19, Ascletis released the preclinical data of ASC11 in COVID-19 that the antiviral potency (EC90) of ASC11 is 31-fold (155/5) of that of Nirmatrelvir. [RH2] ASC11 is an oral small molecule drug candidate targeting 3CLpro, and Ascletis expects that the IND of ASC11 will be filed in the second half of 2022.

19. On April 20, Innovent and Eli Lilly jointly announced the release of the interim analysis of the large Phase III research of Sintilimab Injection in combination with chemotherapy for the first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. The randomized, double-blind, international multicenter research showed that the ORIENT-15 research met the dual primary endpoint – a significant OS benefit in the allover population and the PD-L1 CPS ≥ 10 population.

Launching the clinical trials

20. On April 19, the VV116 tablet, developed by Junshi Biosciences and Vigonvita was registered and started a head-to-head Phase III clinical trial versus Pfizer's Paxlovid, for the treatment of mild to moderate novel coronavirus pneumonia (COVID-19). The VV116, a new-type oral nucleoside analog anti-SARS-CoV-2 drug, can inhibit the replication of SARS-CoV-2.

21. On April 19, drug clinical trial registration and information publicity platform of CDE showed that Betta started a Phase III clinical trial for Ensartinib, evaluating Ensartinib's efficacy and safety in stage II-IIIB NSCLC patients with ALK-positive, who have accepted the complete tumor resection and standard adjuvant therapy, comparing with the placebo. Ensartinib is an ALK inhibitor researched and developed in-house by Betta.

Business

22. On April 18, Roche Pharmaceuticals China announced that it has entered into an innovative collaboration agreement with Teva Pharmaceuticals to combine respective strengths and resources to further expand the availability of the bendamustine hydrochloride original drug in China. This cooperation will lay the foundation for the combination of Teva's bendamustine hydrochloride original drug with Roche's obinutuzumab and polatuzumab vedotin.