The clinical trends of class 1 new drugs in China in November 2019 (2)

Answer: In November 2019, the National Drug Administration (nmpa) drug audit center undertook the NDA application of two Chinese class 1 new drugs and the BLA application of one Chinese class 1 new drug The specific information is shown in the table below: Soventenib (hmpl-012) is independently developed by Hutchison Whampoa Pharmaceutical Co., Ltd It takes orally a new type of vascular immune kinase inhibitor, selectively targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and colony stimulating factor-1 receptor (CSF-1R) In November 2019, the National Drug Administration (nmpa, formerly CFDA) accepted the NDA application submitted by Hutchison Whampoa for suofantinib in the treatment of advanced non pancreatic neuroendocrine tumors In addition, sofantini is still in the clinical phase II / III of the treatment of cholangiocarcinoma, the clinical phase II of the treatment of thyroid cancer, and the clinical phase I of the treatment of solid tumors In the phase I clinical study of solid tumors (nct02133157), sofantini showed a significant effect on neuroendocrine tumors (net) Among the 34 patients, 21 were net patients, the effective rate was 38.1%, the disease control rate was 85.7%, and the median progression free survival time was 16.9 months One In 2017, the results of phase II clinical study (nct02267967) of sofantini on net were announced at the annual meeting of European Society of neuroendocrine Oncology (enets) Of 81 patients with net, 41 were PNET, and 65% were patients who failed in previous systematic treatment As of January 20, 2017, the effective rate of sofantini on pancreatic neuroendocrine tumors was 17.1% (7 / 41), and the disease control rate was 90.2% It is estimated that the median progression free survival of pancreatic neuroendocrine tumors is 19.4 months Two Obutinib is a Btk inhibitor developed by Nuo Cheng Jianhua Pharmaceutical Co., Ltd at present, its new drug application (NDA) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been accepted by China National Drug Administration (nmpa) In addition, this product is also in the first phase of clinical research on the treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), as well as the first phase of clinical research on the treatment of relapsed / refractory CD20 + B-cell lymphoma with recombinant human CD20 monoclonal antibody mil62 injection At the same time, the product is also intended for the treatment of mantle cell lymphoma (MCL), relapsed refractory marginal zone lymphoma (MZL), Fahrenheit megaglobulinemia, etc At present, China's class 1 drugs targeting Btk are as follows: Taitaixipu (Taiai) is a fusion protein developed by Yantai Rongchang Pharmaceutical Co., Ltd It is composed of BLyS / April binding region of transmembrane activator and calmodulin ligand interaction molecule (TACI) and Fc fragment of human immunoglobulin In November 2019, China National Drug Administration (nmpa) accepted the application of blea from Rongchang pharmaceutical for the treatment of systemic lupus erythematosus In addition, the treatment of rheumatoid arthritis (RA) and neuromyelitis pedigree disease (nmosd) is in the third phase of clinical research, while the treatment of Sjogren's syndrome is in the second phase of clinical research Since April 2011, CFDA approved the clinical study of refractory rheumatoid arthritis and systemic lupus erythematosus, the phase I and phase II clinical studies showed good safety One In July 2019, Rongchang biology released the results of r-c18 clinical trial: the key clinical trial of systemic lupus erythematosus reached the main end point This key clinical trial was launched in 2015 It is a multicenter, randomized, double-blind, placebo-controlled study A total of 249 SLE patients were enrolled to evaluate the efficacy and safety of etaxel in the treatment of SLE The results showed that there was a significant difference in the clinical response rate (sri4) between the treatment group and the placebo control group, which was statistically significant, reaching the main end point of the clinical trial The response rate of the high-dose group reached 79.2% in 48 weeks, and that of the placebo control group was 32.0% Etaxel also performed well in terms of safety and patient tolerance Two In December 2017, Yantai Rongchang Pharmaceutical Co., Ltd announced the completion of 1 billion yuan strategic financing, which was jointly funded by Shenzhen Venture Capital, sinoventure, PAG, Longpan investment, sinoventure capital, Huatai health fund, Shandong Jifu venture capital, sinoventure, Luxin venture and Sino Thai Huiyin On November 30, 2009, Gaotou Mingli growth venture capital Co., Ltd (Management Organization: Mingxin China Growth Fund) invested 30 million yuan in Rongchang Pharmaceutical Co., Ltd and obtained 17% equity.