Review of new drug market this week: from January 24, 2022 to January 28, 2022, the top two enterprises in the new drug sector: Maibo Pharmaceutical (+ 7.8%) and Bio-Thera Solutions Ltd(688177) (+ 1.4%); The top 5 enterprises with decline: Deqi Pharmaceutical (- 26.8%), Cinda Biology (- 26.4%), tengshengbo Pharmaceutical (- 26.1%), Yasheng Pharmaceutical (- 25.1%), and gakos (- 25.0%).
Key analysis of the new drug industry this week: on January 31, 2022, the Ministry of industry and information technology and other nine major departments jointly issued the “14th five year plan” for the development of pharmaceutical industry. The plan is prepared according to the 14th five year plan for national economic and social development of the people’s Republic of China and the outline of long-term goals for 2035, which provides a basis for the transformation of pharmaceutical industry to innovation driven in the next five years A practical development path has been formulated to achieve high-quality development.
(1) overall: compared with the requirements of the 13th five year plan, the development goal of the pharmaceutical industry in the 14th five year plan has been further improved
The development goal is the most critical content in the development plan of the whole pharmaceutical industry, and it is also an important basis to judge whether the development of the whole industry meets the planning expectations. According to the data published in the 14th five year plan for the development of pharmaceutical industry, during the last Five-Year Plan period, China basically achieved the development goals set in the 13th five year plan for the development of pharmaceutical industry in terms of industry scale, industrial innovation, supply guarantee and internationalization. Based on the development objectives and achievements during the 13th Five Year Plan period, the development objectives of the 14th five year plan have been further improved.
In terms of industry scale, the development goal of the 13th five year plan is that the average annual growth rate of the main business is higher than 10%, and the development goal of the 14th five year plan is that the average annual growth rate of operating revenue and total profit is maintained at more than 8%.
In terms of industrial innovation, the development goal of the 13th five year plan is that by 2020, the R & D investment intensity of Enterprises above Designated Size in the whole industry will reach more than 2%; The development goal of the 14th five year plan is to increase the R & D investment of the whole industry by more than 10% annually; By 2025, the proportion of new sales of innovative products in the increment of operating revenue of the whole industry will further increase.
In terms of internationalization, the development goal of the 13th five year plan is to strive to reach 10% of export delivery value in sales revenue; The development goal of the 14th five year plan is to make a breakthrough in the “going out” of Chinese patent medicine; Cultivate a number of world-famous brands; A number of large pharmaceutical companies with global layout of R & D and production and high proportion of international sales have been formed.
Based on the achievement of the development goals of the China Meheco Group Co.Ltd(600056) development plan during the 13th Five Year Plan period and the current situation of the vigorous development of innovative drugs in China, we expect that the upgraded development goals listed in the 14th five year plan are also expected to be achieved during the whole 14th Five Year Plan Period. Looking forward to 2035, China Meheco Group Co.Ltd(600056) industrial strength will achieve an overall leap; To form an important pattern of “innovation driven” and “innovation driven” of new drugs in the world; Prominent industrial competitive advantages and upgrading of industrial structure occupy an important position in the global pharmaceutical industry chain; With a wide range of products and excellent quality, we can achieve a higher level to meet the health needs of the people and provide a solid guarantee for building a healthy China in an all-round way.
(2) innovation and development: it is required to strengthen the tackling of key core technologies such as innovative products and industrialization technology
The innovative development plan of pharmaceutical industry in the 14th five year plan puts forward clear development requirements for innovative products and industrialized technologies in the four subdivided fields of chemical drugs, traditional Chinese medicine, biological drugs and medical devices.
Innovative products: the planning requires enterprises to increase investment and carry out the development of innovative products around the unmet clinical needs. Support enterprises based on local resources and advantages, face the global market, focus on new targets and new mechanism drugs, carry out R & D layout, and actively lead innovation. Promote the innovation of traditional Chinese medicine, and develop new traditional Chinese medicine drugs that adapt to the clinical positioning of traditional Chinese medicine and reflect its functional characteristics and advantages. Improve the clinical value oriented guiding principles of drug clinical R & D, strengthen information guidance, and promote enterprises to reasonably layout R & D pipelines.
In terms of industrialization technology: the planning requires that enterprises be supported to integrate scientific and technological resources, tackle key problems around the key technologies, core equipment and new materials in the production of drugs and medical devices, develop, transform and apply a number of advanced technologies, and build new advantages of industrial technology. Focus on improving the production technology of new biological drugs, the innovative process of API, the production technology of high-end preparations, the whole process quality control technology of traditional Chinese medicine, the engineering technology of medical devices and the production technology of key components.
The 14th five year plan for the development of pharmaceutical industry further emphasizes the guiding principle of clinical value oriented drug clinical research and development. We believe that based on the attention paid by regulators to this principle in macro planning, the layout of the R & D pipeline of the whole China Meheco Group Co.Ltd(600056) enterprise is expected to be further optimized and the internal volume will be effectively improved in the future, The whole new drug research and development is expected to expand to more cutting-edge and primitive fields.
(3) internationalization: it is required to form a number of large pharmaceutical companies with global layout of R & D and production and high proportion of international sales
The development goal of the pharmaceutical industry development plan of the 14th five year plan requires the formation of a number of large pharmaceutical companies with global layout of R & D and production and high proportion of international sales during the 14th Five Year Plan period, and defines the goal of international development of China Meheco Group Co.Ltd(600056) enterprises. In addition, the plan also puts forward specific strategies to create international advantages, including:
Attract global pharmaceutical innovation elements to gather in China: Based on the China Meheco Group Co.Ltd(600056) big market, attract global innovative drugs and medical devices to take the lead in registering in China, and shorten the time difference between the listing of innovative products outside China as a whole. Support Chinese clinical research institutions to actively participate in and organize international multi center clinical research and improve the internationalization level of clinical research. Encourage multinational corporations to set up R & D centers and innovative drug production bases in China. Guide Chinese enterprises to introduce foreign advanced technology through cooperative development and technology licensing, improve innovation efficiency and narrow the gap with the international advanced level. Give full play to the policy advantages of Hainan free trade port to facilitate the clinical urgent need of licensed drugs and instruments that have been listed abroad but not listed in China.
Promote China Meheco Group Co.Ltd(600056) enterprises to enter the international market at a higher level: support enterprises to carry out synchronous registration of innovative drugs at home and abroad, carry out global multi center clinical research for the markets of developed countries, and realize the value of innovative drugs in a broader space. Seize the international market opportunities of biological analogues, encourage vaccine manufacturers to carry out international certification, and produce and export vaccines in accordance with international vaccine procurement requirements. Increase the number of generic drugs registered in developed countries and increase the proportion of high value-added products such as first generic drugs and complex preparations. One belt, one road, will speed up the global layout of the industrial chain, encourage enterprises to improve their international market operation capability, and strengthen joint investment in “one belt and one road” investment, and actively explore new pharmaceutical markets.
Consolidate the foundation of international pharmaceutical cooperation: strengthen international drug administration cooperation, deeply participate in the international regulatory coordination mechanism, play an important role in the formulation of relevant guidelines of the international organization for the coordination of human drug registration technology (ICH), actively promote the participation in the international drug inspection cooperation plan (PIC / S), and promote the integration of laws and regulations, mutual recognition of standards and mutual trust in quality between China and foreign countries. By promoting drug regulatory cooperation and mutual recognition with key regions, we will create conditions for more convenient access of pharmaceutical products to the international market. Strengthen exchanges and cooperation with the international herbal medicine Regulatory Cooperation Organization (IRCH) and give play to the global leading role of traditional Chinese medicine standards. We will promote exchanges and cooperation between Chinese and foreign industry organizations in trade promotion, information exchange, industry self-discipline and dealing with frictions, and build a public service platform for international cooperation in medicine.
Approval & acceptance of new drugs this week: this week, 4 new drugs or new indications of new drugs were approved for listing in China, 21 new drugs were approved for ind, 46 new drugs for ind and 6 new drugs for NDA.
Top 3 of China’s new drug industry this week focuses on:
(1) on January 24, the phase 1 clinical data of China’s first mRNA vaccine arcovax (arcov) jointly developed by Aibo biology / Military Medical Research Institute of Military Academy of Sciences / Walvax Biotechnology Co.Ltd(300142) were published in the lancet microbe. The vaccine encodes sars-cov-2spike protein receptor binding domain (RBD), which is safe and well tolerated at all five doses, and strongly induces humoral and cellular immune responses, supporting further large-scale clinical testing.
(2) on January 28, the listing application of Baiji Shenzhou zebutinib new indication was accepted by NDA. The indication is the first-line treatment of adult chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The breakthrough therapy was just incorporated into the program on January 14. At the same time, this application is also the second indication newly declared by zebutinib this month. Previously, on January 18, the listing application of new indications of zebutinib for the first-line treatment of Fahrenheit macroglobulinemia was accepted by NDA.
(3) on January 25, North China Pharmaceutical Company.Ltd(600812) announced that the listing of omativumab was approved. The drug is a recombinant human anti rabies virus monoclonal antibody independently developed in China. It is used in combination with human rabies vaccine to supplement the antibody blank in the process of active immunization of rabies vaccine. It can directly neutralize rabies virus in vivo and play a passive immune role. Previously, the passive immune agents that can be used for the prevention of rabies virus exposure in China were anti rabies serum and rabies patient immunoglobulin.
Top 3 of overseas new drug industry this week focuses on:
(1) on January 25, Pfizer / biontech announced the launch of a clinical trial to evaluate the protective efficacy of Omicron specific vaccine in healthy adults aged 18-55.
(2) on January 25, Gilead announced that due to the obvious imbalance between the study groups of suspected accidental serious adverse reactions (susars) reported by researchers, FDA had partially suspended the joint study of CD47 monoclonal antibody magrolimab + azacitidine.
(3) on January 26, immunocore announced that the FDA approved the listing of its innovative therapy kimmtrak (tebentafusp tebn) for the treatment of uveal melanoma. Kimmtrak is the first FDA approved therapy for unresectable or metastatic uveal melanoma, the first regulatory approved T cell receptor (TCR) therapy, and the first FDA approved bispecific T cell engagers therapy for solid tumors.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
