Tonghua Dongbao's first three generations of insulin glargine obtained clinical approval

According to the website of the State Food and Drug Administration (CFDA) on June 9, the current status of the third generation insulin glargine bulk drug and preparation glargine insulin injection declared by Tonghua Dongbao for clinical use has been changed to "approved pending certification" If there is no accident, the company is expected to get clinical approval within months This is the first clinical approval of three generations of insulin obtained by the company Tonghua Dongbao executives have previously said that the product is expected to be approved in the first half of the year The company has already found a clinical research hospital After the clinical approval of insulin glargine is issued, it will enter the clinical research immediately It is expected to complete the clinical research in the middle of next year and then apply for production Insulin glargine is an insulin analogue, commonly known as "the third generation insulin" The third generation insulin products have been gradually accepted by patients and doctors because of shielding the shortcomings of the second generation products, effectively shortening the treatment time, and good pharmaceutical performance, and become the main drug in the urban insulin market According to CFDA, there are only two domestic manufacturers of glargine insulin injection, namely Sanofi, the original research pharmaceutical company, and Ganli pharmaceutical, the domestic pharmaceutical company However, many domestic manufacturers began to lay out the third-generation insulin market, including Yichang Changjiang Pharmaceutical Co., Ltd., Haizheng Pharmaceutical Co., Ltd., Wanbang Biochemical Co., Ltd and federal Pharmaceutical Co., Ltd under Fosun Pharmaceutical Co., Ltd., which are joint-stock companies of Dongyang Guangke (600673 SH) Tonghua Dongbao and the third generation of insulin Tonghua Dongbao are one of the major manufacturers of insulin products in China At present, their insulin products are mainly the second generation of insulin - human insulin, and their R & D stories of devoting themselves to the third generation of insulin - insulin analogues are quite long, which is also ups and downs The origin of this story has to start with the Ganli pharmaceutical industry In 1998, Ganli was founded, and its main product is the third generation insulin The name of "Gan Li" comes from the surnames of GaN Zhongru, the founder, and Li Yikui, the chairman of Tonghua Dongbao, whose largest shareholder is Tonghua Dongbao But Tonghua Dongbao is not an absolute holding company, and most importantly, Ganli's core technology and control right are still in ganzhongru's hands Seven years later, Ganli's third generation insulin, insulin glargine, came into the market and became one of the few third generation insulin products in the world Because of the agreement with Tonghua Dongbao, the two companies are each in their own field - Ganli is the third generation insulin, Tonghua Dongbao is the second generation insulin But with the development of Gan Li, the idea of independent listing is becoming stronger and stronger In 2010, Gan Li obtained equity investment of 100 million yuan from Qiming venture capital Sure enough, in 2011, Gan Li flew alone In addition to the 400 million yuan equity transfer, Tonghua Dongbao also has a patent technology license for the third generation insulin Tonghua Dongbao can sell the third generation insulin products on the market 42 months after the transfer Therefore, the research and development of Tonghua Dongbao's third generation insulin products must begin Time is still pressing! However, it was not until May 2012 that Tonghua Dongbao completed the preclinical study and applied to start the clinical trial What's more, just half a year later, news came out that two third-generation insulin varieties, insulin glargine and insulin aspart, developed by Tonghua Dongbao, had been withdrawn by the enterprise After the clinical trial application was re conducted, it finally became "under approval" on the 20th of last month At this time, nearly 40 months have passed since "42 months" At present, the research and development of domestic third-generation insulin is fierce The third-generation insulin products on sale mainly come from four enterprises - Novo Nordisk, Sanofi, Lilly and Gan Li, but there are many enterprises engaged in research and development As far as domestic enterprises are concerned, apart from Tonghua Dongbao, Zhuhai Federation and Wanbang pharmaceutical have gone earlier Zhuhai federal started the research and development of the third generation insulin product insulin glargine in 2006, completed clinical trials by the end of 2012, and declared production at the beginning of 2013 (there is no information about the product being put on the market at present) In addition, there are two third-generation insulin products in the research and development process - aspartame insulin obtained clinical approval in April 2013, and Dieter insulin also made clinical application at the end of 2013 Wanbang medicine is a little slower than Zhuhai federal government It started to invest in the research and development of recombinant insulin, and obtained clinical approval in September 2013 The other three third-generation insulin products of Tonghua Dongbao: aspart insulin, laiproline insulin and dieterian insulin are still "under review" on CFDA's website, among which aspart insulin has been under review since February last year, and the other two products have been under review since December last year In addition, Haizheng pharmaceutical, which is transforming from API, is also distributing insulin products So far, it has applied for clinical approval of five insulin products, two of which belong to the third generation of insulin - insulin glargine and insulin asparagus The latter clinical application has just been accepted After the news that the clinical approval document of Tonghua Dongbao Ganjing insulin is about to be approved came out, the stock price of the fourth enterprise's Fenshi third generation insulin market didn't rise much, and the market didn't seem particularly excited about the news However, the future of the third-generation insulin market is still worth looking forward to According to the CMH terminal monitoring data of Zhongkang information, in 2013, the scale of China's insulin market was 14.48 billion yuan, of which the third generation insulin products accounted for 39.2% As mentioned above, the third generation insulin products in China mainly come from four enterprises, of which Novo Nordisk has the highest market share, accounting for 45.2% of the market, followed by Sanofi and Lilly, and Ganli is the only domestic enterprise, accounting for about 6.5% of the market Compared with the second-generation insulin, the third-generation insulin has obvious advantages It is even claimed that the third-generation insulin will eventually replace the second-generation insulin In fact, in recent years, the growth rate of the third generation insulin products is relatively fast, with a year-on-year growth of 27.9% in 2013, higher than 23.5% of the whole insulin market Specific to the four enterprises, Novo Nordisk still has the fastest growth rate, 29.2%, followed by Gan Li, 28.0% With more and more enterprises investing in the research and development and production of the third generation insulin products, the current simpler market format is about to change.