According to Jiaodong Online on January 4, 2022, on January 1, 2022, the new version of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2021 Edition) was officially implemented. Two world-class new biological drugs independently developed by Rongchang Biopharmaceutical (Yantai) Co., Ltd. (Taiai) and Vidicetizumab (Edich) ushered in the first "medical insurance prescription". It is reported that the two "medical insurance prescriptions" were issued by Tang Yanchun, director of the Department of Rheumatology and Immunology of Yantai Yuhuangding Hospital, and Xu Huiting, director of the Department of Abdominal Oncology of Hubei Provincial Cancer Hospital, on January 1 and January 4, respectively.
Tang Yanchun, director of the Department of Rheumatology and Immunology at Yantai Yuhuangding Hospital, is prescribing a prescription
Tatacipu's first "Medicare Prescription" patient was a 21-year-old woman
Xu Huiting, director of the Department of Abdominal Oncology of Hubei Provincial Cancer Hospital, prescribed the first "medical insurance prescription" of vidicetizumab
On December 3, 2021, the world's first dual-target biological new drug for the treatment of systemic lupus erythematosus, Tetaczep, and China's first self-developed ADC new drug, vidicetizumab, were included in the new version of the national medical insurance drug catalogue through national medical insurance negotiations. Since then, Rongchang Bio has actively implemented the national regulations on drug list, and in just one month, these two world-class new drugs have successively issued the first "medical insurance prescription". In the future, these two new drugs will achieve medical insurance reimbursement in more hospitals across the country, changing the treatment and payment status quo of more systemic lupus erythematosus patients and patients with advanced gastric cancer, so that they can fully benefit.
Tang Yanchun, director of the Department of Rheumatology and Immunology at Yantai Yuhuangding Hospital, said: "Systemic lupus erythematosus can affect multiple systems in the body, and timely control of disease activity and reduction of hormone dosage are the main goals of treatment. As the world's first dual-target biologic in the field of systemic lupus erythematosus treatment, tetasip acts on both APRIL and BlyS ligands, which can inhibit the maturation and differentiation of B cells and inhibit the secretion of autoantibodies by plasma cells, and its clinical response rate of SLE can be as high as 70%, and the risk of severe recurrence is reduced by 56%, which greatly improves patient prognosis and helps patients obtain better quality of life. ”
Xu Huiting, director of the Department of Abdominal Oncology of Hubei Provincial Cancer Hospital, said: "Advanced gastric cancer has strong heterogeneity, poor prognosis, limited choice of third-line treatment drugs, low efficiency, short disease-free survival, short overall survival, and urgent treatment needs. Vidicetizumab, as the first nationally created original research ADC drug listed in the field of advanced gastric cancer treatment, can accurately target HER2 IHC2+ and 3+ patients without FISH detection, and has an efficiency rate of 24.8% for third-line patients with advanced gastric cancer, a disease control rate of 41.7%, and a median survival of 7.9 months, which is comparable to the current second-line standard drug efficacy and greatly improves the prognosis of patients. ”
-About Ta xipu (Tai Ai)
Tetacip (trade name: Taiai) is the world's first, first-in-class recombinant B lymphocyte stimulating factor (BLyS)/proliferation-inducing ligand (APRIL) dual-target new fusion protein product independently developed by Rongchang Biology, which can simultaneously inhibit the binding of BLyS and APRIL to B cell surface receptors, and "two-pronged" to prevent abnormal differentiation and maturation of B cells, thereby treating autoimmune diseases. Due to the characteristics of new targets, new structures and new mechanisms, Ttaxipu invention patents have been authorized by China, the United States, Europe and other countries and regions, and have been supported by major scientific and technological projects of "major new drug creation" during the national "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan". On March 9, 2021, the indications for tetacil systemic lupus erythematosus were approved for marketing and sale by the State Drug Administration, and were included in the new version of the national medical insurance directory on December 3 of the same year. At present, the drug is used in the field of autoimmune diseases for 7 indications (including systemic lupus erythematosus, optic nerve myelitis spectrum disease, rheumatoid arthritis, IgA nephropathy, Sjögren's syndrome, multiple sclerosis and myasthenia gravis, etc.) are in the commercial or clinical trial stage, of which the global multicenter clinical research of systemic lupus erythematosus phase III and IgA nephropathy phase II is steadily advancing.
-About vidicetizumab (Edich)
Vidicetizumab (Edich) is China's first original antibody conjugated (ADC) drug developed by Rongchang Biology, targeting the HER2 protein on the surface of the tumor, which can accurately identify and kill tumor cells, and has achieved world-leading clinical data in clinical trials for the treatment of gastric cancer, urinary tract carcinoma, breast cancer and other tumors, and is the first ADC drug in China to obtain dual recognition by the US FDA and the China Food and Drug Administration for breakthrough therapy. On June 8, 2021, the indications for vidicetizumab gastric cancer were approved for marketing and sales by the China Food and Drug Administration, and were included in the new version of the national medical insurance catalogue on December 3 of the same year, and were included in the "Guidelines for the Clinical Application of New Anti-tumor Drugs (2021 Edition)" on December 27. The marketing application for urinary urothelial carcinoma indications has been accepted by the China Food and Drug Administration and included in the priority review, and the phase II/III clinical research on the treatment of breast cancer, lung cancer, cholangiocarcinoma and other indications is being promoted, of which breast cancer indications have been officially included in the breakthrough treatment varieties by CDE. In August 2021, Seattle Gene, an internationally renowned biopharmaceutical company, obtained the exclusive global (excluding Asia Pacific) license agreement for vidicetizumab with a down payment of up to US$2.6 billion and milestone payments, from high single digits to more than 15% gradient sales commission, and the transaction volume once set a new record for the highest overseas authorization of a single variety of Chinese pharmaceutical companies.
- About Rongchang Bio
Founded in 2008, Rongchang Biopharmaceutical (Yantai) Co., Ltd. is headquartered in Yantai Economic and Technological Development Zone, Yantai Pilot Free Trade Zone, China (Shandong), with R&D centers and branches in Beijing, Shanghai, San Francisco and Washington. On November 9, 2020, Rongchang Biotech was listed on the Hong Kong Stock Exchange, raising a total of US$590 million, setting a record for the world's largest biotech IPO that year.
Edited by Chen Yuanyuan