Cinda Biologics Picks Up 7th Heavyweight Variety Of 25 Innovative Drugs Revealed

Recently, Xinda Biologics has been flooded with good news: pemetinib tablets approved in mainland China, introduction of Lilly Remusizumab, revenue exceeding 4 billion yuan in 2021 ...... The company's first innovative drug PD-1 sales exceeded 3 billion yuan, 3 new indications are on the way, and the market leadership is solid. In addition to the 7 new drugs that have been approved for production, Xinda Biologicals currently has 25 new drugs under development, focusing on the 100 billion anti-tumor drug track, Seputinib has been submitted for marketing, 5 new drugs in the critical clinical stage, into the pipeline rapid harvest period.

　　On 6 April, Cinda Biologics announced that Dapertan (pemigatinib tablets, pemigatinib) was approved for marketing by the State Drug Administration. Dapertan was co-developed by Incyte and Sindbio, with Sindbio being responsible for commercialisation in mainland China, Hong Kong, Macau and Taiwan. This approval in Mainland China is another important milestone following the approval in Taiwan, China in June 2021 and Hong Kong, China in January 2022. Daberoten is also the first selective FGFR receptor tyrosine kinase inhibitor to be approved in China.

　

　　On 29 March, Cinda Biologics announced its 2021 results. Measured in accordance with non-IFRS standards, the Company's total annual revenue was RMB4.261 billion, an increase of 74.1% over the same period last year, of which RMB4.001 billion was product revenue, an increase of 69% year-on-year.

　　During the reporting period, Sindbio's commercial product portfolio expanded to six approved drugs, including Darbysol (sindilizumab injection), Dayoton (bevacizumab biosimilar), Sulisin (adalimumab biosimilar), Darbovac (rituximab biosimilar), Darbactam (pemetinib) and Nerik (orebactinib).

　　As Sindbio's first commercial product, the PD-1 inhibitor Daberoxu (Sindilizumab injection) maintains its market leadership position with continued strong sales value and volume growth. Sales revenue of Dabosu will exceed RMB3 billion in 2021 and RMB2.29 billion in 2020.

　　In addition, among the PD-1 monoclonal antibodies included in the national medical insurance catalogue, tirelizumab and treprolizumab have disclosed sales data. The annual report shows that Baekje Shenzhou's tirelizumab sales revenue in 2021 will be US$255 million (over RMB1.6 billion, at the average exchange rate in 2021), up 56% year-on-year; Junshi Biologics' treprolizumab sales revenue will be RMB412 million, down 59% year-on-year.

　　At present, Sindilizumab injection has been approved for a total of four indications and successfully entered the national medical insurance catalogue, including first-line non-squamous non-small cell lung cancer, first-line squamous non-small cell lung cancer, first-line hepatocellular carcinoma and classic Hodgkin's lymphoma. In addition, Sindilizumab injection has three new indications under registration, including first-line esophageal cancer, first-line gastric cancer, and EGFR-mutated non-squamous lung cancer.

　　Commercialisation prominence! Taking the 7th heavyweight variety

　　Since the birth of its first commercial product, Cinda Bio's annual product revenue has grown from RMB1 billion to RMB4 billion in three years, with the company's commercialisation capability continuously proven and its commercialisation portfolio in the process of expansion.

　　The Company has actively entered into a series of business collaborations with Baoyuan Pharmaceuticals, Yashang Pharmaceuticals, Jinfang Pharmaceuticals and UNIION to develop or commercialise a number of innovative and differentiated products.

　　On 28 March, Cinda Biologics announced an agreement with Eli Lilly and Company for the exclusive commercialisation rights to import, market, promote and distribute Cilanzide (ramucirumab) and Retsevmo (ceputinib) in mainland China upon approval, as well as granting Cinda Biologics the right of first negotiation for the future commercialisation of Pirtobrutinib (BTK inhibitor) in mainland China. .

　　Remusizumab, a fully human IgG1 monoclonal antibody that binds specifically to VEGFR-2, was approved for marketing by the State Drug Administration on March 16, making it the first and only targeted drug approved for second-line treatment of advanced gastric cancer in China. According to Lilly's financial report, the sales revenue of ramucirumab is US$1,033 million in 2021.

　　The expansion of the strategic collaboration with Eli Lilly marks the seventh approved product and a near-commercial product for Cinda Biologics, as well as the further expansion of its extensive oncology product pipeline.