Tonghua Dongbao's six clinical trials of new drugs have been withdrawn by the enterprise

On January 31, Xinbang Pharmaceutical (002390) was sealed on the drop board all day On the evening of January 30, Xinbang pharmaceutical announced that the company will conduct a series of additional studies and tests in accordance with the guiding principles for clinical trials of new Chinese medicine in treating stroke (Draft for discussion) issued by the State Food and Drug Administration in May 2012, so the application for production registration of new ginsenoside Rd will be withdrawn Tonghua Dongbao (600867), the largest insulin manufacturer in China, also suffered from the new drug Waterloo after Xinbang pharmaceutical's new drug approval was blocked On January 31, our reporter inquired in the drug evaluation center of the State Food and Drug Administration and learned that on December 27, 2012, the application for clinical trials of six new drugs, insulin glargine and insulin asparagus, developed by Tonghua Dongbao, had been withdrawn by the enterprise "The company has not obtained information about these varieties, and is currently discussing the matter internally, and may issue an explanation in an announcement on February 1," said Gu Liping, a representative of Tonghua Dongbao securities On May 17, 2012, the above two kinds of insulin entered the clinical research stage, and the clinical progress has not been disclosed so far The continuous withdrawal of new drug applications by enterprises makes the capital market very sensitive to such information On January 31, Tonghua Dongbao shares fell 2.11% to close at 12.04 yuan after rising nearly 50% in a month In fact, Tonghua Dongbao's share price has been soaring continuously It was after December 27, 2012 that Tonghua Dongbao withdrew the application for clinical trial of the new drug Problem exposure At present, only a few enterprises in the world, such as Novo Nordisk, Sanofi and Ganli pharmaceutical, can produce the third generation insulin Tonghua Dongbao is the largest insulin manufacturer in China, whose products are mainly the second generation insulin The industry generally calls animal insulin the first generation, human insulin the second generation, and synthetic insulin analogues the third generation The third generation insulin is more close to the insulin naturally secreted by human body in all aspects, and has gradually become the mainstream of diabetes treatment At present, only a few enterprises in the world, such as Novo Nordisk, Sanofi and Ganli pharmaceutical, can produce the third generation insulin Tonghua Dongbao, UL and other enterprises are stepping up their research and development in order to share the food market share In 2011, the domestic insulin market sales volume was about 10 billion yuan, of which Novo Nordisk's revenue was DKK 6.2 billion (nearly 7 billion yuan) Therefore, Tonghua Dongbao's concept of the third generation insulin has been favored by many institutions On December 31, 2012, Societe Generale Securities issued the communication minutes of tonghuadongbao, saying that tonghuadongbao "has applied for phase III clinical treatment of two specifications of insulin analogues and is still waiting for approval" If the information of Societe Generale Securities is true, Tonghua Dongbao is expected to catch up with the pace of UL Because in December 2012, UL announced that it had completed the clinical trials of the third generation insulin and entered the production approval stage But in fact, it took three years from September 2009 to the end of clinical trials Therefore, it is impossible for Tonghua Dongbao to withdraw its phase III clinical application It is generally believed in the industry that Tonghua Dongbao should have problems before clinical trials For all kinds of claims, Gu said the company is investigating, but it will take time for the results to be fed back Tonghua Dongbao has made a response strategy Gu Liping said: "I heard that the company has submitted the application report to the review center and has been accepted The original report may be flawed, considering that the supplementary information takes longer than re application, so the withdrawal method is adopted But that doesn't represent the company's official statement " That is to say, Tonghua Dongbao may need to wait more than three years from the acceptance of the review center Obviously, in the competition of the third generation insulin, Tonghua Dongbao has fallen behind However, in September 2011, in the price adjustment of insulin carried out by the national development and Reform Commission, the price of second-generation insulin produced by domestic and foreign enterprises was adjusted to 65 yuan, which made Lilly, Novo Nordisk and other enterprises lose the pricing advantage, while Tonghua Dongbao got a good opportunity in the market Therefore, the current Tonghua Dongbao only relies on the second generation of insulin to have a more nourishing life In the first three quarters of 2012, the sales volume of Tonghua Dongbao was 716 million yuan, an increase of more than 20% over the same period last year In 2011, Tonghua Dongbao transferred the equity of Ganli pharmaceutical industry, and obtained 400 million yuan of income If this factor is not considered, the actual loss of the company in 2011 is about 40 million yuan In the first three quarters of this year, the profit has reached 132 million yuan New product dystocia As long as Ganli pharmaceutical has any technical reservation, Tonghua Dongbao will take many detours Ganli pharmaceutical has a deep relationship with Tonghua Dongbao, which is also the reason why it decided to develop the third generation insulin On March 1, 2011, Tonghua Dongbao announced that it would transfer 29.43% of its shares in Ganli to other shareholders of Ganli pharmaceutical at a price of no less than 400 million yuan After the transfer, Tonghua Dongbao and Gan Li broke up completely, and Gan Li sought independent listing