Weekly Pharma News Review | PharmaSources.com (March 21 to 25)

Henlius PD-1 was launched this week, becoming the 7th China-made PD-1 monoclonal antibody and the 13th PD-1/PD-L1 monoclonal antibody that was marketed in China. The pharma news review of this week covers a total of 18 news in 3 sections, i.e. review approval, R&D, and listing. 

Review Approval

NMPA 

Marketing 

1. On March 21, it was shown on the CDE official website that Trastuzumab Deruxtecan for Injection (DS-8201) from Daiichi Sankyo/AstraZeneca was declared for marketing for the first time. DS-8201 is a HER2-targeting anti-body-drug conjugate (ADC). In March 2019, AstraZeneca signed a global cooperative development and commercialization agreement with Daiichi Sankyo for obtaining the DS-8201 with an initial payment of US$ 1.35 billion + potential milestones of US$ 5.55 billion. 

2. On March 22, it was shown on the CDE official website that the Romiplostim for Injection, a biological medicine of Class 3/4 from Qilu Pharma, was declared for marketing. It was originally developed as Romiplostim by Kyowa Kirin. Romiplostim is the second generation of oral TPO-R agonist that has been approved for marketing by the FDA and EMA for the second-line treatment of immune thrombocytopenic purpura. 

3. On March 24, an approval document was published by the NMPA official website, saying that the Henlius-made PD-1 monoclonal antibody - Serplulimab - was approved for marketing for the treatment of unresectable or metastatic highly microsatellite unstable (MSI-H) solid tumors that have failed standard therapy. It is the 7th PD-1 monoclonal antibody that was made in China. 

4. On March 24, it was shown on the NMPA official website that the recombinant human papillomavirus bivalent (16/18) vaccine made by the Yuxi Zerun Biotechnology, a subsidiary of Walvax, was approved for marketing. The bivalent HPV vaccine can be used for the prevention of cervical cancer caused by HPV 16 and 18 virus infections. 

5. On March 24, it was shown on the NMPA official website that the New Drug Application for Brigatinib, an ALK inhibitor, submitted by Takeda has been approved. It is a new generation of potent selective tyrosine kinase inhibitor (TKI) designed to target anaplastic lymphoma kinase (ALK) molecular variation. 

6. On March 24, NMPA made the latest announcement that the marketing application for a new indication of the combination therapy of Dabrafenib and Trametinib submitted by Novartis has been approved. According to the public information of priority review, the combination therapy is approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) who are positive for BRAF V600 mutations. 

Clinical Trials 

7. On March 22, it was publicized on the CDE official website that the SSGJ-617 Injection declared by Sunshine Guojian obtained the implied permission for clinical trials, and the proposed indication is advanced solid tumors. SSGJ-617 is an antagonistic antibody targeting PSGL-1 researched and developed by Verseau Therapeutics, and Sunshine Guojian owns its rights and interests in Greater China. 

8. On March 23, it was shown on the CDE official website that a new indication of KL130008 Capsule, a new drug of Class 1 from Sichuan Kelun Biotech, has been approved for clinical application. KL130008 Capsule is an innovative small-molecule JAK inhibitor independently researched and developed by Kelun Pharmaceutical with intellectual property rights and is intended for the treatment of rheumatoid arthritis. 

9. On March 23, it was publicized on the CDE official website that the Obicetrapib Tablet declared by New Amsterdam Pharma obtained the implied permission for clinical trials and is intended as adjuvant therapy to diet and MTD lipid-lowering therapy. Obicetrapib is an oral selective cholesteryl ester transfer protein (CETP) inhibitor being researched by New Amsterdam. 

Breakthrough Therapy 

10. On March 22, it was publicized on the CDE official website that the Alprazolam Inhalation Powder declared by UCB Pharma and Alexza is proposed to be included in the category of breakthrough therapy, which is for the rapid termination of prolonged episodes of tonic-clonic epilepsy in patients aged 12 years and older. Alprazolam Inhalation Powder is a small hand-held oral inhalation first aid therapy for epilepsy, Staccato alprazolam. 

11. On March 24, it was publicized on the CDE official website that the FKC889 declared by Fosun Kite is proposed to be included in the category of breakthrough therapy and is intended to be developed for the treatment of relapsed/refractory mantle cell lymphoma (MCL). FKC889 is a CAR-T cell therapeutic drug that Fosun Kite induced from KitePharma and industrialized and commercialized in China.

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Priority Review 

12. On March 24, it was shown on the CDE official website that the New Drug Application of Sucroferric Oxyhydroxide Chewable Tablet is proposed to be included in the priority review, and the indication is hyperphosphatemia. According to public information, this tablet is a non-calcium, iron-based and chewable phosphate binder, which has been approved for marketing overseas.

FDA 

13. On March 20, PersonGen announced that its Chimeric Antigen Receptor (CAR) T-Cell Injection targeting B7-H3 (R&D code: TAA06 injection) has obtained the qualification of orphan drug granted by the US FDA for the treatment of neuroblastoma. 

14. On March 22, Ascentage Pharma announced that APG-115, a new drug under development, has obtained the certification for Rare Pediatric Disease (RPD) granted by the FDA to treat neuroblastoma. APG-115 is an oral, highly selective MDM2-p53 inhibitor independently researched and developed by Ascentage Pharma and has received 1 Fast Track qualification, 6 Orphan Drug Designations (ODD), and 2 certifications for Rare Pediatric Disease granted by the FDA. 

15. On March 24, Novartis announced that the FDA has approved the marketing of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy and androgen receptor pathway inhibition. This is the first FDA-approved targeted radioligand therapy for the treatment of patients with such mCRPC. 

R&D 

16. On March 21, CSPC Pharmaceutical Group Co., Ltd announced that the anti-RANKL antibody JMT103 of JMT Bio, a subsidiary of the group, has reached the preset endpoint in pivotal clinical trials for the treatment of giant cell tumors of bone that are either unresectable or difficult to operate. Based on the results of this research, CSPC Pharmaceutical Group Co., Ltd has applied to NMPA for pre-marketing communications. 

17. On March 21, Zai Lab released detailed data for the Phase 3 clinical research (PRIME) of Niraparib as maintenance therapy. Research showed that the statistically and clinically significant improvement in PFS with tolerable safety can be achieved with Niraparib as maintenance therapy in Chinese patients newly diagnosed with ovarian cancer following platinum-based chemotherapy, regardless of biomarker status. 

Listing 

18. On March 23, Shouyao Holdings was officially listed on the Sci-Tech Innovation Board of the Shanghai Stock Exchange. Shouyao Holdings adopt the fifth set of listing standards of the Sci-Tech Innovation Board, and the sponsor institution (lead underwriter) is China Securities. According to the prospectus, 6 new drugs of Class 1 that are researched and developed independently by the company have entered the stage of clinical trials. 

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.