The news review of this week is from March 7 to 12, covering a total of 20 pieces of information in 4 sections, i.e. review, R&D, business, and listing.

Approval & Review

NMPA

Marketing

1. On March 9, Innovent announced that its biosimilar Bevacizumab Injection (brand name: BYVASDA) was officially approved by NMPA for two new indications. It can be applied with carboplatin and paclitaxel for the first-line treatment of patients with Stage III or IV epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma after initial surgical resection, and can also be applied with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of patients with persistent, recurrent or metastatic cervical carcinoma.

2. On March 11, the NMPA official website revealed that Hansoh Pharmaceutical Group's CD19 monoclonal antibody Inebilizumab was approved for marketing in neuromyelitis optica spectrum disorder (NMOSD). This is the first biological drug approved for marketing by Hansoh. In May 2019, Hansoh acquired the development and commercialization rights of the drug in China from VielaBio for more than USD 220 million in down payment and milestone payments.

3. On March 11, the NMPA official website revealed that a new indication marketing application of PD-1 inhibitor, Tislelizumab, of BeiGene, has been approved. It can be applied for previously treated locally advanced unresectable or Microsatellite Instability-High (MSI-H) or deficient DNA mismatch repair (dMMR) solid tumors.

4. On March 11, NMPA’s official website revealed that CSTONE Pharmaceuticals received marketing approval for a new indication of pralsetinib capsules. It can be applied for the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, as well as those with advanced or metastatic RET fusion-positive thyroid carcinoma requiring systemic therapy and refractory to radioactive iodine (if radioactive iodine is indicated).

5. On March 11, the NMPA official website revealed that the marketing approval for the Class 5.1 new drug, nitric oxide for inhalation, of Zhaoke Pharmaceutical. Nitric oxide for inhalation (brand name: INOmax) is a vasodilator that selectively allows pulmonary vascular relaxation and improves oxygenation in the vulnerable neonatal population by combining it with an air interchanger and other appropriate medications.

6. On March 12, NMPA issued an announcement to approve the application changes of COVID-19 antigen self-testing products application of Beijing Savant Biotechnology Co., Ltd., Nanjing Vazyme Biotech Co., Ltd, Beijing Jinwofu Bioengineering Tech, Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd, and Guangzhou Wondfo Biotech Co., Ltd. Just in one night, there are five such products officially marketed in China, and the market valued RMB 100 billion for COVID-19 self-testing in China is officially open.

Clinical

7. On March 7, the CDE official website revealed that JS001SC, a PD-1 monoclonal antibody subcutaneous injection from Junshi Biosciences, was approved for the first time in China (acceptance No.: CXSL2101506) for advanced nasopharyngeal carcinoma. JS001SC injection is a subcutaneous injection formulation developed by Junshi Biosciences on the basis of the marketed product, Toripalimab injection.

8. On March 7, Hengrui Medicine announced that the Phase 3 clinical trials for a new indication of the investigational JAK1 inhibitor, SHR0302 tablets, were approved by NMPA, targeting active non-radiographic axial spondyloarthritis. According to publicly available information, SHE0302 has already been in Phase 3 clinical development for various indications.

9. On March 8, CDE newly announced that enpatoran, which was filed by Merck, Germany, was approved clinically in China for the indication of systemic lupus erythematosus (SLE). According to public information, enpatoran is a potential "first-in-class" oral TLR 7/8 inhibitor developed by Merck, Germany. It is proposed to be developed for the treatment of cutaneous lupus erythematosus, systemic lupus erythematosus, and other indications, and it is currently in Phase 2 clinical research overseas.

10. On March 7, Sihuan Pharm announced that XZP-KM257, a Class 1 new drug independently developed by its subsidiary Xuanzhu Biopharm, was approved for clinical use in advanced solid tumors with high expression in HER2+ (acceptance No.: CXSL2101488). KM257 is a recombinant anti-HER2 structural domain II and structural domain IV bispecific antibody.

11. On March 8, the CDE official website announced that Otsuka Pharmaceutical filed an investigational new drug for VIS649 and was accepted. According to public information, VIS649 is an anti-APRIL monoclonal antibody, which was acquired by Otsuka Pharmaceuticals in 2018 after the acquisition of Visterra. It is currently in Phase 3 clinical trials overseas and is intended to be developed for the indication of IgA nephropathy.

12. On March 8, Sino Biopharmaceutical announced that the investigational new drug of its independently developed Class 1 new drug TDI01 suspension for the treatment of pneumoconiosis has been approved by NMPA for clinical trials. According to public information, TDI01 is an oral small molecule drug with a new target and a new mechanism and is a highly selective inhibitor that targets Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2). It was previously approved for clinical trials in China for idiopathic pulmonary fibrosis.

13. On March 9, Bio-Thera announced the clinical approval of an ADC new drug, BAT8006, for advanced solid tumors (acceptance No.: CXSL2101528). This is the third ADC new drug developed by Bio-Thera since two ADC projects were terminated in succession. BAT8006 consists of a recombinant humanized anti-FRα antibody linked to a toxic small molecule topoisomerase I inhibitor by a shearing linker developed independently.

14. On March 9, CDE announced that Immune-Onc Therapeutics submitted an investigational new drug for IO-108 injection in China and it was accepted. According to public information, IO-108 is a potential "first-in-class" novel inhibitory antibody targeting LILRB2, which is proposed to be developed for the treatment of solid tumors. The drug has previously been approved for clinical use in the U.S. and is undergoing Phase 1 clinical research.

15. On March 10, the CDE official website revealed that AstraZeneca's AZD8233, an antisense oligonucleotide (ASO) drug targeting PCSK9 obtained through a collaboration between AstraZeneca and Ionis, was approved for clinical use in hypercholesterolemia (acceptance No.: JXHL2101272) and is currently in clinical Phase II clinical trials.

16. On March 10, the CDE official website announced that SCG101 autologous T-cell injection of SCG Cell Therapy Pte Ltd was granted a clinical trial implied license for the treatment of hepatitis B virus (HBV) relevant hepatocellular carcinoma (HCC). According to public information, SCG101 is a T-cell therapy of an autologous T-cell receptor (TCR) targeting specific hepatitis B virus epitopes, a potential novel therapy for HBV-related hepatocellular carcinoma and is currently in Phase 1 clinical trials overseas.

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R&D

17. On March 7, according to the drug clinical trial registration and information publicity platform of CDE, Chiatai Tianqing registered to initiate a Phase III clinical trial of PD-L1 monoclonal antibody TQB2450 sequential combination therapy for the first-line treatment of advanced non-squamous NSCLC, in a head-to-head study with Tislelizumab of BeiGene (registration No.: CTR20220484)

18. On March 11, according to the drug clinical trial registration and information publicity platform of CDE, InventisBio had initiated Phase 3 clinical trials of D-0502 for the treatment of locally advanced or metastatic breast carcinoma. D-0502 is an oral selective estrogen receptor degrader (SERD) and estrogen receptor antagonist developed by InventisBio. It is currently undergoing international multi-center clinical trials in China and the U.S.

Transaction & investment and financing

19. On March 10, Pfizer and Genertec Sinopharm jointly announced a supply agreement for the combination packaging of the therapeutic drug for SARS-CoV-2 treatment, PAXLOVID. Genertec Sinopharm will be responsible for the commercial operation of Pfizer's therapeutic drug for SARS-CoV-2 treatment, PAXLOVID in the Chinese Mainland during the term of the agreement.

Listing

20. On March 11, Serum Bio-Technology was officially listed in the Science and Technology Innovation Board, Shanghai Stock Exchange. Founded in 1999, Serum Bio-Technology is a biopharmaceutical company focused on the field of anti-serum antitoxins, dedicated to the research and development of preventive and therapeutic drugs for biotoxins and biosecurity.