Medical Network December 7th 2017 is about to pass, with the in-depth implementation of drug registration reform, what is the change in corporate reporting strategy? Which varieties are more hotly declared? What are the characteristics of these varieties?

According to the author's statistics, as of November 22, 2017, 77% of the applications for registration of products in 2017 were chemical drugs, 15% were for registration of biological products for treatment, and 4 for preventive biological products and Chinese medicines. %.

In chemical drug applications, Class 1 registrations accounted for 44%, and new registration category 4 and old registration category 6 production registrations accounted for 31%. It can be seen that the declaration of generic drugs that have been listed in China has warmed up.

The heat of class 1 chemical is still not reduced

Due to the fierce competition of generic drugs, the enthusiasm of pharmaceutical companies to fight the runway of Class 1 chemical drugs has been rising. This year, the declaration of Class 1 chemical drugs has continued to be high.

Dongyang Sunshine, Hengrui and Zhengda Tianqing are the three largest companies that have applied for the registration of chemical drugs in the first class in 2017. The number of acceptance numbers is close to 20. The proportion of chemical drugs listed in the three major enterprises accounted for 29%.

The products declared by Dongyang Sunshine Pharmaceutical Co., Ltd. have anti-Alzheimer's disease new drug HEC30654AcOH raw materials and capsules, anti-hepatitis drug Kangda Ruiwei sodium and tablets, HEC68498 sodium salt and capsules, HEC74647PA raw materials and capsules, and risaloprene raw materials. And film. The above products have not been included in the priority review and approval list.

The products declared by Hengrui System include SHR0532 raw materials and tablets, SHR9549 raw materials and tablets, and SHR7280 raw materials and tablets for treating endometriosis, which are suitable for painful μ opioid receptor (MOR) agonist SHR8554 and Injection, tryptophan metabolism enzyme IDO inhibitor SHR9146 raw materials and tablets, treatment of breast cancer, pyrrolidine maleate raw materials and tablets. Among them, the production declaration of raw materials and tablets of pyrrolidine maleate has been included in the list of priority review and approval.

In addition, Hengrui's c-Met ADC (antibody drug conjugate) injection is a new class 1 drug for therapeutic use, which has been approved for clinical use in the US FDA.

The products declared by Zhengda Tianqing System include TQ05105 raw materials and tablets, TQ05510 raw materials and capsules, TQ-A3326 raw materials and tablets, TQB3455 raw materials and tablets, TQB3456 raw materials and tablets, TQB3616 raw materials and capsules for the treatment of medullary thyroid carcinoma. And rolotiniol hydrochloride raw materials and capsules for tumors other than small cell lung cancer. Among them, the production declaration of erlotinib hydrochloride capsule has also been included in the list of priority review and approval.

The products of Class 1 new drugs are produced in addition to Hengrui's pyrrolidine maleate and Ernstinitan hydrochloride, as well as Zibojin (China) rostastat raw materials and capsules for treating renal anemia. Hutchison Whampoa furazotinib raw material and capsule for non-small cell lung cancer, Zhejiang medicine sodium naprofloxacin sodium chloride injection. Among them, Hutchison Whampoa furazolinib was also included in the list of priority review approvals, and the raw materials and capsules of naloxalin malic acid were approved in 2016.

The listed chemical drugs have been warmed up

The new classification of chemical drugs in category 4 refers to the domestic applicants copying the drugs that have been listed in the domestic market. This type of medicine should be consistent with the quality and efficacy of the original drug, and it mainly corresponds to the 6 categories of the old registration of chemical drugs.

Compared with the new registration category 4 of chemical drugs, the new registration category of chemical drugs has higher requirements, and the clinical trials that need to be done are more complicated and costly. Therefore, the newly registered four categories of chemical drugs with relatively low cost have attracted many pharmaceutical companies.

The same is true from the filing data. Since the CFDA promulgated the generic drug BE filing system, in 2017, a total of 115 new acceptance numbers for chemical drugs were declared for production.

Statistical drug new 4 (old 6) products in 2017 can be found in the declaration of tenofovir disoproxil fumarate tablets, the largest number of manufacturers, five companies are Shijiazhuang Longze Pharmaceutical, Anhui Anke Hengyi Pharmaceutical, Suzhou Terui Pharmaceutical, Anhui Baker Biopharmaceutical and Hangzhou Supor Nanyang Pharmaceutical. Domestic manufacturers of tenofovir disoproxil fumarate have Chengdu Bite, Qilu Pharmaceutical, Anhui Baker and Zhengda Tianqing. The latter three are approved in 2017. In the future, there are so many enterprises that declare their listings and the competition is fierce. .

In addition, 4 cases of moxifloxacin hydrochloride tablets, vildagliptin tablets and gefitinib tablets were reported respectively.

The manufacturers of moxifloxacin hydrochloride tablets are reported by Chongqing Huabang Pharmaceutical, Nanjing Youke Pharmaceutical, Guangdong Dongyang Pharmaceutical and Nanjing Shenghe Pharmaceutical. Moxifloxacin hydrochloride tablets have not been approved by the first imitation manufacturer. Moxifloxacin hydrochloride injection has been listed in Chengdu, Tiantaishan and Nanjing Youke. The products that started clinical after 2016 are Sichuan Guowei and Zhejiang Haizheng. Guilin South Medicine, Hunan Tianji Caotang, Shenzhen Xinlitai and Jiangsu Tianyi. The company that has been included in the priority review list for moxifloxacin hydrochloride tablets is Beijing Wansheng Pharmaceutical.

The corresponding manufacturers of vildagliptin tablets are Qilu Pharmaceutical, Nanjing Youke Pharmaceutical, Beijing Tide Pharmaceutical and Jiangsu Haosen Pharmaceutical. There is no first imitation manufacturer approved for viglietin tablets. Yantai Wanrun Pharmaceutical Co., Ltd. has initiated the clinical record of BE. The clinical trials have also been initiated by Shandong Luoxin and Yangzijiang Pharmaceutical Group Sichuan Hairong.

Gefitinib tablets are reported by Zhengda Tianqing Pharmaceutical, Nanjing Youke Pharmaceutical, Hunan Kelun Pharmaceutical and Jiangsu Hengrui Pharmaceutical . Gefitinib tablets are currently only listed on Qilu Pharmaceutical, and the product has been included in the list of priority review approvals.

Gefitinib tablets in clinical started business after 2016 there CSPC Pharmaceutical Europa, a Connaught Shanghai Pharmaceutical, Sichuan American and Kang Huakang Pharmaceutical, Jiang Su Tianshi Dili Yi Pharmaceutical, Dalian Zhen-Ao Pharmaceutical, Suzhou Terui Pharmaceutical, Zhejiang Huahai Pharmaceutical and Yangzijiang Pharmaceutical.

Ranked by the number of application acceptance numbers, Shijiazhuang Group ranked first in the European pharmaceutical industry. In 2017, the products declared were dasatinib tablets, metformin hydrochloride tablets and sustained-release tablets, pramipexole hydrochloride tablets, and hydrogen chloride chloride. Pyrogram tablets, sunitinib malate capsules and ticagrelor tablets. Among them, metformin hydrochloride tablets and sustained-release tablets and clopidogrel hydrogen sulfate tablets have been included in the list of priority review and approval, and are expected to be double-reported products for rapid approval.

In 2017, Zhejiang Huahai Pharmaceutical Co., Ltd. reported duloxetine enteric-coated capsules, donepezil hydrochloride monohydrate and donepezil hydrochloride tablets, voriconazole tablets, serodosin capsules and valsartan hydrochlorothiazide tablets.

Zhengda Tianqing and Foshan Deyi can be tied for third.

Zhengda Tianqing declares lenalidomide capsules, saxagliptin tablets, gefitinib tablets, ambrisentan tablets, apixaban tablets and abiraterone acetate tablets. Among them, the Abitrone tablets for the treatment of prostate cancer are currently only listed in the domestic market. Dr. Ruidi Lab of India, Shengdi Medicine of Chengdu, Shanxi Shanxiang Pharmaceutical and Qilu Pharmaceutical are clinically reported through BE filing, and Chengdu Shengdi Medicine also In 2017, abiraterone acetate tablets were produced.

Foshan Deco Co., Ltd. is a subsidiary of Faude Biotech. In 2017, it was acquired by Sihuan Pharmaceutical. Sihuan Medicine can register the medicines developed by its affiliated generics research institute in line with the European and American markets, and can be registered in the United States and the European Union through the production in Germany, and further develop the international layout of preparations. Foshan Deyi can declare two products in 2017, which are quetiapine fumarate sustained release tablets and glibenclamide tablets.

Therapeutic biological products monotherapy is the hottest

Vaccines and monoclonal antibodies are two of the hot spots in the bioproducts program.

Domestically produced products have also begun to take shape in the field of vaccines where imported products are clearly dominant. The declaration of domestic preventive biological products is mainly based on vaccines, especially influenza vaccines. The Shanghai Institute of Biological Products and Changchun Haijiya have the largest number of biological declarations. There are many enterprises that apply for the tetravalent influenza virus split vaccine, including Hualan Biological, Changchun Haijiya and Changchun Changsheng.

The declared products for therapeutic biological products are mainly monoclonal antibodies. Among them, PD-1 antibody drugs and PD-L1 antibody drugs are hot spots. The global new drug PD-1 antibody drug has been marketed 2 products, PD-L1 antibody drug has been listed 3 products, and China's PD-1 antibody drug has also entered phase III clinical, such as Cinda's IBI-308.

In 2017, the companies that applied for a large number of therapeutic biological products included Jiahe Biopharma, Sichuan Kelun Botai Biomedicine and Jiangsu Hengrui Medicine, each with three product declarations.

The development of monoclonal antibodies can be described everywhere, and the main pressure will come from drug prices and project costs. In addition, due to the large number of patients and fewer patients, the clinical recruitment of the project will face competition.

Chinese patent medicines are all oral medicines

The research and development of traditional Chinese medicine, which has been sluggish in recent years, has finally shown signs of recovery this year. At present, the research project has changed its dosage form as the main point of view, and it is mainly based on oral preparations, especially the dosage forms suitable for children .

From the data of the Chinese medicine project being declared, the applicants include Hutchison Whampoa Pharmaceutical, Jichuan Pharmaceutical, Yangzijiang Pharmaceutical, Hangzhou Zhongmei Huadong Pharmaceutical, Jiangsu Kangyuan Pharmaceutical and Yunnan Baiyao Group, etc. The products are basically oral drugs.

Jichuan Pharmaceutical changed its superior product to syrup. In 2017, it applied for Pudilan anti-inflammatory syrup and Pediatric sputum clearing syrup.

summary

In 2017, the domestically reported chemical drug production report finally recovered. From the point of view of the application, the reform of the registration regulations does not prevent the company from reporting enthusiasm for products with high sales potential.

From the company's 2017 filing data, you can see which companies are actively responding to the registration regulations reform and adjust their product development reporting strategies. For example, Hengrui, the first pharmaceutical company with a market value of over 200 billion yuan, has a layout in the hot spots of chemical drugs, 1st, 3rd, 4th, and therapeutic biological products. Zhengda Tianqing and Dongyangguang reported the first class of chemical drugs in 2017, and the new four types of data were eye-catching. Coron is working on three types of chemical drugs and therapeutic biological products.

How to win in the homogenization competition will be the next question that enterprises need to think about.