This is a year full of joy and change. No matter from the policy environment of the entire pharmaceutical industry or the perspective of enterprises, numerous opportunities and challenges are driving the innovation and upgrading of the industry.

1 The national 863 plan major anti-tumor innovative drug "Chidaniline" was approved for global marketing

Chidamide, a Chinese original anti-cancer drug, is the world's first subtype-selective histone deacetylase oral inhibitor approved for marketing, and it is also the first original innovative drug in China to be licensed for use in developed countries such as the United States. The launch of Chidaniline marks a significant improvement in China's core technologies and capabilities in the whole process of structure-based molecular design, target research, safety evaluation, clinical development and industrialization. It is a historic breakthrough in my country's pharmaceutical industry.

2 Xiansheng Merck joint venture company dismantled

Simcere Pharma Co., Ltd. announced a strategic adjustment. The local pharmaceutical company Simcere Pharma is solely responsible for the operation and management of the joint venture; the joint venture company Simcere and Merck will transform and focus on local drugs (including generic drugs and national first-class drugs). operation of new drugs, etc.).

3 Zhongyu New Drug Receives China's First FDA Breakthrough Therapy Designation

Zhongyu New Drug announced that its new HIV drug TMB-355 for intravenous injection has been approved by the FDA for breakthrough therapy. Qualifications.

4 The State Council officially issued a document to support "Internet + medical care" will become the next outlet

The State Council's Guiding Opinions on Actively Promoting the "Internet Plus" Action was officially announced. The "Guiding Opinions" proposed to vigorously develop emerging consumption with Internet as a carrier and online and offline interaction, and accelerate the development of Internet-based medical care, health, pension, social security, etc. Emerging services; encourage the pharmaceutical industry to use the e-commerce platform to optimize the procurement and distribution system, and improve the efficiency of business operations.

5 The disease risk database project was included in the list of proposed projects for Shanghai Innovation Fund

The "Disease Risk Database" project developed by Metz Medical was listed in the "2015 Shanghai Science and Technology SME Technology Innovation Fund Proposed List" announced by the Shanghai Municipal Science and Technology Commission. This is the first large-scale application of big data-related technologies in the systematic organization of knowledge about disease onset and prognosis. It can help guide the further direction of medical research, improve the clinical diagnosis and treatment model of certain diseases, and help basic medical researchers discover relevant signals. Access, pathology researchers understand disease etiology, clinical laboratory physicians develop new test items, and clinicians predict the treatment and outcome of diseases, which provide convenience and meet the needs of scientific researchers to improve the efficiency of related literature retrieval.

6 New breakthroughs in innovative drugs overseas! Hengrui to sell PD-1 mAb to Incyte for $795 million

Hengrui Medicine announced that the company will license the PD-1 monoclonal antibody project (SR1210) with independent intellectual property rights for tumor immunotherapy to Incyte in the United States. worldwide exclusive clinical development and marketing rights outside the territories.

7 BGI announced that Mei Yonghong joined as the head of the National Gene Bank

BGI announced that Mei Yonghong, the former deputy secretary of the Jining Municipal Party Committee and mayor of Shandong, will join BGI and serve as the head of the Shenzhen National Gene Bank. Mei Yonghong has more than 20 years of working experience in the Ministry of Agriculture and the Ministry of Science and Technology. Before becoming the mayor of Jining, she served as the Director of the Department of Policy, Regulation and System Reform of the Ministry of Science and Technology for many years.

8 Luye New Drug is expected to become the first Chinese new drug approved for marketing in the United States

Luye Pharma announced that the U.S. FDA has agreed to accept its risperidone microsphere sustained-release injection LY03004 for filing through the 505(b)(2) route, and no further clinical trials are required beyond the already completed pivotal Phase 1 clinical trial. Human clinical studies. It is expected that Luye Group will submit an NDA to the FDA within two years, which signifies that Luye, and also China's first new drug, will soon enter the US market.

9 Milestones total over $1 billion! Innovent and Eli Lilly once again to develop innovative antibodies

Innovent and Eli Lilly have reached a global development cooperation agreement for three tumor immunotherapy bispecific antibody drugs, with a total milestone payment of over US$1 billion, making it the largest international biopharmaceutical cooperation project in China so far. The establishment and further expansion of the strategic alliance between the two parties is the first domestic enterprise in China to reach a comprehensive cooperation with a global top 500 enterprise in the field of high-end biopharmaceuticals from research and development, registration, production to sales, creating an innovative model for Chinese biopharmaceutical enterprises and international cooperation. .

10 Doctor Chunyu was shot while lying down. The mobile medical model remains to be explored

An article titled "On the Fall of Doctor Chunyu" pushed the mobile medical company Chunyu to the forefront of public opinion, while raising questions about the Internet medical model. Zhang Rui, CEO of Chunyu, said that mobile medical care is a brand new industry, and there is no object to learn, copy or imitate, so you have to do it yourself.

11 Hutchison Whampoa and BeiGene submit IPO plans to raise $100 million in the United States

Hutchison Whampoa and BeiGene have successively filed initial public offering (IPO) applications with the U.S. Securities and Exchange Commission (SEC), planning to raise $100 million in funds. Nasdaq Market.

12 Former BGI CEO Wang Jun announced to start a business and focus on artificial intelligence

Former BGI CEO Wang Jun announced the establishment of Shenzhen Carbon Yuan Technology Co., Ltd. The company's co-founders also include former BGI Chief Operating Officer Wu Chun, Chief Scientist Li Yingrui and Chief Information Officer Li Hao. It is reported that iCarbonX is planning to build a health big data platform, which will use artificial intelligence technology to process these data to help people manage their health.

13 China is about to launch a precision medicine program

According to the National Health and Family Planning Commission, my country is currently formulating a "precision medicine" strategic plan, which may be included in the 13th Five-Year Plan for major science and technology projects. In March this year, the Ministry of Science and Technology held the country's first precision medicine strategy expert meeting and proposed China's precision medicine plan. The meeting pointed out that by 2030, my country will invest 60 billion yuan in the field of precision medicine.

14 The storm of drug registration verification strikes, and several pharmaceutical companies withdraw their applications

According to the requirements of the Announcement on Carrying out Self-inspection and Verification of Drug Clinical Trial Data and the Announcement on Carrying out Self-inspection of Drug Clinical Trial Institutions, CFDA has conducted on-site inspection of clinical trial data for some drug registration applications that have submitted self-inspection materials. A total of 24 drug registration applications were rejected twice. As of now, the CFDA announcement shows that 62 companies have voluntarily withdrawn 87 applications for drug registration.

15 Policy Blossoms in the Cell Therapy Field

Since the beginning of this year, the state has issued a series of policies aimed at promoting the development of the cell therapy field: In February, the Ministry of Science and Technology released the "National Key Research and Development Program Stem Cell and Translational Medicine Key Special Implementation Plan" for comments), and launched the national key research and development program "Stem Cells". In May, the National Health and Family Planning Commission canceled the approval for the clinical application of the third type of medical technology including hematopoietic stem cell transplantation, gene chip diagnosis, immune cell therapy, etc.; in August, the National Health and Family Planning Commission and CFDA Jointly released my country's first "Administrative Measures for Stem Cell Clinical Research"; in December, the National Health and Family Planning Commission and CFDA issued a notice to initiate the filing of stem cell clinical research institutions. The introduction of these policies has undoubtedly laid the foundation for the standardized development of the immune cell and stem cell therapy industry.

16 The 2015 edition of the Pharmacopoeia of the People's Republic of China was officially implemented

The 2015 edition of "Chinese Pharmacopoeia" was officially implemented: the new Pharmacopoeia added 1,082 new varieties on the basis of the 2010 edition of the Pharmacopoeia, and the total number of recorded varieties reached 5,608. In order to ensure the safety of medication, the requirements for safety control have been increased and improved. It mainly controls the excess of sulfur dioxide, heavy metals, pesticide residues, ash, etc., as well as harmful substances such as mycotoxins, pigments, and harmful elements, microorganisms, and related pathogenic bacteria.

17 Registration Network changed its name to WeDoctor Group, and the financing amount hit a new high

In September, WeDoctor Group (Gaohao.com) announced a financing of US$394 million. Later, a subsidiary of Fosun Pharma announced that it intends to subscribe for nearly 40 million E-round preferred shares of registration.com, with a total subscription amount of about US$65 million. According to industry analysis, the total market value of the registration network has exceeded 1.5 billion US dollars, which is the combined market value of several other leading mobile medical companies in China.

18 Ikang Guobin launched the poison pill plan: preventing the hostile takeover of Jiangsu Sanyou

After Ikang Guobin announced the start of privatization at the end of August, Jiangsu Sanyou announced that it would participate in the submission of a non-binding privatization transaction offer to Ikang Guobin, and authorized the company to participate in the submission of preliminary bids. Zhang Ligang, chairman and CEO of iKang Guobin, made it clear that he rejected the privatization offer, and then launched the "poison pill plan" to prevent Jiangsu Sanyou (Meinian Health has completed the backdoor of Jiangsu Sanyou at a price of 5.5 billion yuan) through malicious Acquired the controlling stake of iKang Guobin.

19 Kangfang Bio announced that it has reached a tumor immune cooperation with Merck & Co.

Kangfang Bio announced that Merck will obtain the exclusive global development and promotion rights for the immune checkpoint blocking antibody AK-107 developed by it. Abiotic Bio will receive an upfront payment from Merck, as well as tranche payments totaling $200 million covering development and commercialization. This is the first Chinese innovative biotechnology company to successfully license a new monoclonal antibody drug completely independently developed to the world's top five pharmaceutical giants.

20 Health and Family Planning Commission launched a healthy China construction plan

Since the communiqué of the Fifth Plenary Session of the 18th CPC Central Committee put forward the new concept of "Healthy China", the National Health and Family Planning Commission has recently launched the preparation of the "Healthy China Construction Plan (2016-2020)" and has begun to solicit public opinions from the public. The plan will become a programmatic document for promoting the construction of a healthy China in the next five years, and related industries and companies in the medical and health field may usher in a good opportunity for rapid development.

21 The birth of the first online prescription for an Internet hospital

On December 10, the first online prescription was issued at Wuzhen Internet Hospital, the first Internet hospital in the country. An electronic prescription promotes the "marriage" between Internet hospitals and physical tertiary hospitals, and realizes the collision and integration of physical medical institutions and "Internet +".

22 WuXi AppTec announced the completion of privatization or the spin-off of the three major businesses to be listed separately

Wuxi PharmaTech, a Chinese concept stock, announced the completion of its privatization after the close of the day and was delisted from the New York Stock Exchange, with a market value of US$3.3 billion. According to people familiar with the matter, WuXi PharmaTech has completed the privatization, and the next step is most likely to split its CRO business, CMO business and gene business into three major companies, which will be listed in China.