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 included in breakthrough therapy. It is for advanced cervical cancer that has failed or is intolerant to first-line and above platinum-containing chemotherapy. IBI310 is an Ipilimumab biosimilar. Ibritumomab was developed by BMS and approved for marketing by FDA in 2011.

10. On April 6, CDE’s official website revealed that Chiatai Tianqing's PD-L1 monoclonal antibody TQB2450 is proposed to be included in breakthrough therapy. It is for the treatment of recurrent or metastatic endometrial cancer with non-microsatellite high instability (non-MSI-H) or non-DNA mismatch repair deficiency (non-dMMR) that has failed or cannot tolerate previous treatment with first- or second-line chemotherapy regimens.

FDA 

Marketing Application

11. On April 1, FDA announced the approval of an expanded indication of Yescarta, a CD19-targeted CAR-T therapyof Gilead’s subsidiary, Kite Pharma, for adult patients with large B-cell lymphoma (LBCL) refractory to first-line chemoimmunotherapy or progressing within 12 months. This is the first CAR-T therapy to be approved for a second-line indication in the world.

12. On April 6, Novartis announced that FDA has granted accelerated marketing approval to Alpelisib (brand name: Vijoice) for treating adults and pediatric patients aged 2 years and above with severe PIK3CA-related overgrowth spectrum (PROS) who need systemic treatment. Alpelisib is the first therapeutic drug for PROS approved by FDA.

Clinical

13. On April 3, Junshi Biosciences announced that the Investigational New Drug of anti-CD112R monoclonal antibody injection for the treatment of advanced solid tumors has been approved. The anti-CD112R monoclonal antibody is a recombinant humanized IgG4 monoclonal antibody targeting CD112R for the treatment of advanced malignant tumors. No product targeting CD112R has been approved for marketing in China or abroad currently.

EMA

14. On April 6, BeiGene announced that EMA has accepted the Marketing Authorization Application (MAA) for PD-1 monoclonal antibody Tislelizumab (brand name: Baizean) for two major cancer types, esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC). First-line and second/third-line therapies for NSCLC indications are currently approved in China, and second-line ESCC indications are under review.

R&D

15. On March 31, the drug clinical trial registration and information publicity platform of CDE revealed that Alphamab Oncology's PD-L1/OX40 bispecific antibody KN052 was registered for the first time to initiate clinical trials in China. KN052 is a PD-L1/OX40 nano-bispecific antibody, in which the OX40 agonist antibody is in the form of Fab and DF004 of Dingfu Biotarget is selected, while that of PD-L1 is in the form of nano-antibody.

16. On March 31, drug clinical trial registration and information publicity platform of CDE revealed that I-Mab Biopharma's TJ-CD4B, a CLDN18.2/4-1BB bispecific antibody, was registered for the first time to initiate clinical trials in China. TJ-CD4B is the first innovative bispecific antibody targeting tumor antigen tight junction protein 18 splice variant 2 (Claudin18.2) and T cell co-stimulatory molecule 4-1BB to enter the clinical stage.

17. On April 6, Kintor Pharmaceuticals announced key data results from the Phase III clinical trials (NCT04870606) of proxalutamide[HR1]  for the treatment of outpatients infected with mild and moderate COVID-19. The data showed that proxalutamide was effective in reducing hospitalization/mortality and could significantly and consistently reduce SARS-CoV-2 load.

Business

18. On April 7, Harbour BioMed announced a global out-licensing agreement with AstraZeneca for the development and commercialization of HBM7022. HBM7022 is a bispecific antibody targeting the tumor-associated antigen Claudin18.2 (CLDN18.2) and CD3, developed by Harbour BioMed, and is currently in the preclinical phase.