Three class 1 new drugs + PD-L1 approved clinical, Hengrui pharmaceutical R & D strength to reach a new high

Excellent content on December 14, Hengrui pharmaceutical announced that the company and its subsidiaries Shanghai Hengrui, Jiangsu Shengdi and Chengdu Shengdi have recently received the approval opinion notice and clinical trial approval document approved and issued by CFDA The above documents are related to four major products, including the new diuretic and antihypertensive drug shr0532 tablets and APIs, ido1 / TDO inhibitor shr9146 tablets and APIs, small non peptide thrombopoietin receptor (tpor) agonist haemapopamide tablets, humanized anti-PD-L1 monoclonal antibody shr-1316 injection SHR0532, a new type of diuretic antihypertensive drug, was reported to be accepted by the Jiangsu pharmaceutical and Food Administration Bureau on January 2017 * 4, by Heng Rui medicine, Jiangsu Sheng Di and Shanghai Heng Rui The SHR0532 is a small molecule compound specifically inhibiting ROMK It is intended to be used as a diuretic for the treatment of water and sodium retention and hypertension The approved clinical shr0532 includes tablet and API, among which tablet includes three specifications: 0.5mg (calculated by tartrate), 5mg (calculated by tartrate) and 25mg (calculated by tartrate) Mk-7145, a similar drug developed by Merck, is the first ROMK inhibitor to enter the clinical trial stage in the world Currently, there is no ROMK inhibitor on the market at home and abroad Shr0532 tablet is a new type of diuretic and antihypertensive drug It is a class 1 new drug jointly developed by Hengrui pharmaceutical and Shanghai Hengrui and has independent intellectual property rights Up to now, the company has invested about 11.5 million yuan in shr0532 and film R & D projects On March 29, 2017, sho9146, an ido1 / TDO inhibitor, Hengrui pharmaceutical, Shanghai Hengrui, Jiangsu Shengdi and Chengdu Shengdi submitted the drug registration application to Sichuan food and Drug Administration for acceptance Shr9146 is an oral, efficient and selective ido1 / TDO inhibitor intended for the treatment of malignant tumors The approved clinical shr9146 includes tablets and APIs, including two specifications of 25mg and 100mg tablets At present, there are no Ido inhibitors on the market at home and abroad There are two kinds of IDO inhibitors under research in the world, one is ido1 inhibitors represented by epacadostat, the other is ido1 and TDO double target inhibitors represented by gdc-0919 In clinical trials, Ido inhibitors are often combined with other therapies to treat advanced solid tumors The development of IDO inhibitors is still in its infancy in China, and the products independently developed by domestic companies have not yet entered the clinical stage Up to now, the company has invested about 16.8 million yuan in shr9146 and film R & D projects Small non peptide thrombopoietin receptor (tpor) agonist haetripopamide tablets Hengrui medicine and Shanghai Hengrui submitted the application for drug registration to Jiangsu food and Drug Administration on May 26, 2017, which was accepted Haitrapopanethanolamine, a small non peptide thrombopoietin receptor (tpor) agonist absorbed orally, is intended to be used in the treatment of aplastic anemia The approved clinical haitripopa ethanolamine tablets include three specifications: 2.5mg (calculated by c25h22n4o5), 3.75mg (calculated by c25h22n4o5) and 5mg (calculated by c25h22n4o5) Data source: the performance database of MNCs in minai.com currently has promacta ® developed by GSK company as its similar products on the market in foreign countries (etrapa), an oral, small molecule, non peptide second-generation tpo-r agonist, was approved by FDA and European Drug Administration in 2014 and 2015 respectively for the treatment of severe aplastic anemia with poor efficacy of immunosuppressive therapy This product has not been approved in China In March 2015, Novartis successfully completed the asset replacement transaction with GSK Novartis acquired GSK's tumor business with us $16 billion, which included promata ® (etrapopa) According to GSK's annual report data, in 2014, the global sales of promata ® (etrapa) were 231 million pounds (US $310 million at real-time exchange rate) After the products were classified into Novartis, the sales continued to rise, and the global sales in 2016 had exceeded US $635 million Up to now, Hengrui pharmaceutical has invested about 72.2 million yuan in the research and development project of haitripopa ethanolamine tablets Human anti-PD-L1 monoclonal antibody shr-1316 injection Hengrui medicine and its subsidiary Shanghai Hengrui submitted the drug registration application to Jiangsu food and Drug Administration on January 3, 2017, which was accepted Shr-1316 injection is a kind of human anti-PD-L1 monoclonal antibody independently developed by the company, which is mainly used for the treatment of malignant tumors The approved clinical injection of shr-1316 has a specification of 12ml: 0.6g At present, there are three kinds of similar products on the market in foreign countries, namely atezolizumab (trade name tecentriq ®), avelumab (trade name bavencio ®) and durvalumab (trade name imfinzi ®) Tecentriq, developed by Roche, was first approved by FDA in May 2016, with a specification of 1200mg / 20ml It is the first PD-L1 inhibitor on the market, which can be used to treat metastatic bladder cancer and non-small cell lung cancer patients with targeted drugs and chemotherapy failure According to the performance database of MNCs on midnet, tecentriq's global sales in 2016 were CHF 157 million (US $155 million at real-time exchange rate) In addition, bavencio ® was jointly developed by Merck and Pfizer and approved by FDA in March 2017 The specification is 20mg / ml, which is suitable for Merkel cell cancer treatment Developed by AstraZeneca and approved by FDA in May 2017, imfinzi ® is suitable for the treatment of metastatic bladder cancer All of the above three products are in phase III clinical trials in China At present, other domestic PD-L1 antibody products with clinical approval issued by CFDA include kn035 (acceptance No cxsl1600033) jointly developed by Corning jerui / thingdi, cs1001 (acceptance No cxsl1600075) jointly developed by cornerstone pharmaceutical / Tuoshi pharmaceutical and kl-a167 (acceptance No cxsl1700026) jointly developed by Kelun pharmaceutical Up to now, the company has invested about 34 million yuan in the R & D project of shr-1316 injection Source: public announcement of listed companies, Internet Database