2018 pharmaceutical usher in slow market | is expected to accelerate the resumption of market structure

Pharmaceutical Network January 3 last year, December 29 last year, the State Food and Drug Administration released the first batch of generic drugs through the quality and efficacy of the consensus assessment of the drug announcement, a total of 12 drugs, involving 17 items of drug regulations passed. A shares 4 listed companies on the list.

Through the generic drug quality and efficacy of conformance evaluation (hereinafter referred to as 'conformance evaluation') drug , The State Food and Drug Administration directly included in the "list of Chinese listed drugs," the directory set known as the Chinese Orange Book.

According to a research report released by Orient Securities, the first year of the adoption of the generic version of the generic drug of consistency in China will be 2018 and the starting point for the realization of import substitution in the real sense of generic drugs in China will be achieved. "The variety of conformity assessment is expected to rapidly realize import substitution, , To my country medicine The development of the industry has a huge impact.

According to reporter statistics, the adoption of the drug through the consistent evaluation enterprise Including the A-share listed company letter Litas, Hyundai Pharmaceutical (600,420, Shares), Huahai Pharmaceutical, Hisun Pharmaceutical (600,267, Shares), Hong Kong-listed company under the China Biopharmaceutical Nanjing Chia Tai Fine Pharmaceutical Co., Ltd., in addition Qilu Pharmaceutical, Chengdu Biotech Pharmaceutical Co., Ltd. also passed the product.

Hyundai announced on December 30 last year that the first batch of cefuroxime axetil tablets (250mg) produced by Zhijun (Shenzhen) Pharmaceutical Co., Ltd., a subsidiary of Sinopharm Group, passed the evaluation of the consistency of the quality and efficacy of generic drugs. Litai also released the first batch of the company to pass the consensus assessment of clopidogrel bisulfate tablets (75mg).

Huahai Pharmaceutical is the first batch of winners through the consistency assessment. Huahai Pharmaceutical losartan potassium tablets (2 specifications), lisinopril tablets (2 specifications), irbesartan tablets, Erbesha Hydrochlorothiazide tablets, fosinopril sodium tablets, risperidone tablets, paroxetine hydrochloride tablets were passed. Hisun Pfizer's irbesartan tablets (3 specifications) were approved.

Prior to this, Haizhenghui Ruifa Bulletin said that the company's tacrolimus capsule did not pass drug consistency assessment, mainly due to the product in 2015 after the original registration of the European countries have not re-registered, can not provide the original listing in recent years, clinical Usage and Adverse reactions Information, and this product is a narrow therapeutic index drugs in the country, China's BE test of such drugs have the relevant technical requirements, foreign BE test data show that the Cmax 90% confidence interval of 105.563% -117.928%, did not fall on the narrow Treatment window drug requirements 90.00% -111.11% range.

Drug consistency assessment, related to the business market.

The Opinions of the General Office of the State Council on Evaluation of Consistency in the Quality and Curability of Generic Drugs released in 2016 shows that in order to encourage enterprises to conduct a generic drug consistency assessment, the state will support the policy, including the adoption of a consensus assessment drug variety , With due support in respect of medical insurance payments, medical institutions should give priority purchase And preferred in clinical application.With the same variety of drugs through the consistent evaluation of the production enterprises to reach more than 3, in the centralized procurement of medicines and other aspects are no longer selected without consistency assessment of varieties and so on.

Hyundai Pharmaceutical said that the first batch of shares of Sinopharm Medicine, which is the subsidiary of Sinopharm Medicine, would be beneficial to the future market sales and market competition of the product and accumulated valuable experience in the follow-up evaluation of other products. It will have a positive impact on the operating results of Zhijun Zhijun and the Company.

Xintai said that Taijia (clopidogrel bisulfate tablets) is the drug of choice for anti-platelet aggregation, and the national second-class new drug is promising in the market under the policy of "giving priority to procurement and use of products that have passed the consensus evaluation" .

In this context, the competition for key varieties of enterprises can be described as intense.Rasuguvastatin calcium tablets is one of the key drugs market concerns, the Nanjing CTT Pharmaceutical Co., Ltd. the first batch of approved, to the Lu Nan Beit Pharmaceutical Co., Ltd., Beijing Xin Pharmaceutical (002020, Shares) and other manufacturing enterprises under pressure.

Beijing New Pharmaceutical announced on December 29 last year, the company received the State Food and Drug Administration Drug Evaluation Center Rosuvastatin on the calcium supplement issued by the notice, the company to provide additional information. The company has issued a notice in accordance with the requirements, It is worth mentioning that, after the new pharmaceutical Jingruo rosuvastatin calcium tablets were reviewed by the Center for Drug Evaluation, causing the company's stock price volatility.

The full implementation of the generic drug consistency assessment will make the generic drug quality and efficacy consistent with the original research drug. It is an important measure to enhance the overall development level of the pharmaceutical industry in our country, optimize the product structure, improve the drug quality and ensure the safety of the public drug use.

State Food and Drug Administration issued a notice clearly: 'approved before the implementation of the new classification registration of generic drugs, including domestic generic drugs, imported generic drugs and original research drug products of the real estate, should carry out consistent evaluation; Where in 2007 The approved generic drugs for oral solid preparations included in the National Essential Drug List (2012 version) that are listed before October 1 should be, in principle, to be evaluated in consensus before the end of 2018 '.

In addition to oral solid preparations, the Drug Evaluation Center of the State Food and Drug Administration announced on December 22 last year, on the public solicitation of "technical requirements for the consistency of the listed chemical generic drugs (injections) evaluation," the notice. The views of the same chemical injection The preliminary evaluation of the technical requirements for the initial description of the comments deadline for January 25, 2018. Injection start consistency assessment, the speed exceeded expectations.

'From a general trend of view, as the industry standard improves, low-quality varieties will gradually be kicked out of the market, and high-quality varieties will gain greater policy advantages and market advantages. "Pharmaceutical industry market participants told reporters.