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Russia – China: development of biopharmaceutical technologies on the basis of cooperation

From August 25 to 28, a representative delegation of Chinese entrepreneurs and scientists specializing in the field of pharmaceutical production and biotechnology paid a working visit to Moscow. The visit was organized by Sinopharmtech LLC and ChengduYingdeBiologicalPharmaceuticalEquipment & TechnologyCo., Ltd with the support of the information project "GMP News".

Within the framework of the official visit, two main events were held, one of which was a working meeting of the management of the State Institute of Medicines and Good Practices and representatives of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia with representatives of biopharmaceutical companies in China.

The main subject of the meeting was the search for opportunities for cooperation in the field of biopharmaceuticals and the acquaintance of guests with the Russian legislation regulating the production and turnover of pharmaceutical and biopharmaceutical products. Particular attention during the meeting was paid to the issue of conducting inspections at foreign sites. As for Chinese industries, then, according to statistics, out of 32 GMP inspections conducted by FSI "GILS and NP" for the period 2016 – the 1st half of 2019, only 17 Chinese manufacturers of medicines received a conclusion on compliance with the standards of good manufacturing practice.

Zhu Hanjun:General Director of Sinofarmtezh LLCSu Xiaodong: CEO of Chengdu Yingde Biological Pharmaceutical Equipment & Technology

Representatives of "SID and NP" recalled that during the preparation of russian GMP rules, EU rules were taken as a basis. However, since the release of the latest version of the Rules of Good Manufacturing Practice of the Russian Federation (Order No. 916 as amended by the Order of the Ministry of Industry and Trade of Russia dated 18.12.2015 No. 4148), a number of changes have occurred in the EU GMP rules, which were reflected in the new versions of the GMP sections. These changes concern personnel, premises and equipment, production, quality control, complaints and product recalls. In particular, the chapter on personnel now spells out in detail the responsibility of senior management in the management of the Pharmaceutical Quality System, and in the description of key personnel there was a mention of the head of the department, etc.

The parties also discussed the prospects for cooperation in the field of engineering. The engineering and design department of "SID & GP" is ready to assist Chinese companies in the implementation of project documentation of the "Conceptual Design" stage of production sites (buildings, plants) in GMP-critical areas: technological, architectural and planning solutions, heating, ventilation and air conditioning, as well as conducting technical audits – assessing the compliance of production with GMP requirements.

The Forum on the Development of Biopharmaceutical Technologies and Business Cooperation, held on August 27, was attended by representatives of 8 leading profile companies in China and more than 30 representatives of Russian manufacturing companies and research centers.

The business program of the forum was opened by Wang Yongsheng, Vice President of Jinyu Bio-Technology, China's largest company for the development and production of vaccines for animals. The expert raised the problem of epidemics of foot-and-mouth disease and African swine fever, which can have a huge impact not only on health, but also on the economy as a whole. The problem is really acute for almost all countries, since currently vaccines against such dangerous diseases have not yet been developed.

The development of domestic veterinary science and scientific relations with China in this area was told by a Russian scientist in the field of veterinary virology and industrial biotechnology, Academician of the Russian Academy of Sciences, Doctor of Veterinary Sciences, Professor Anatoly Yakovlevich Samuylenko.

The representative of the state-owned company Weiguang Biological, the manager of the blood purification shop Huang Yuebing, focused on the features of work and the prospects for cooperation in the conditions of a biotechnological industrial park. As a basis for interaction, the company offers an integrated platform that includes not only production facilities, but also research centers, experimental stations, an academic base of researchers in the field of development and production of blood products, vaccines, recombinant proteins, diagnostic reagents.

Fan Kan, CEO of PEG-BIO Biopharm, spoke about the research activities and development of new drugs. The main objects of study of the company are insulins, pegylated therapeutic enzymes, tandem-expressing peptides, lead and intermediate peptides, recombinant enzymes that have a unique commercial potential.

Zuo Jinbo, Director of marketing at Shandong Kingtong Biotechnology, made a presentation on the use of vitamin C in biological materials. The expert noted that Shandong Kingtong Biotechnology is engaged in the development of biotechnological products, in particular pharmaceutical intermediates, on the basis of an industrial park in the Taian high-tech zone. In its activities, the company relies on advanced scientific research and innovative approaches. The developments of the enterprise have broad prospects in the market, due to the science intensity and low cost of production.

Professor Bai Jonghu, representing Jiangnan University, devoted his speech to the innovative system of expression of the foreign protein corynebacterium glutamicum, the optimization of which is currently in the focus of attention of scientists. Bai Jonghu also spoke about such areas as the creation of protein growing technology and the development of the Crisp/cas9 gene editing system. The University has published a number of scientific articles on these topics. Bai Jeonghu stressed that at the moment there is an excellent opportunity for pharmaceutical companies to bring this knowledge to life by starting the production of advanced drugs. The university provides unique equipment for screening and commercial evaluation of developments. The professor also presented the biopharmaceutical company Transcenta, which includes research and development centers in Suzhou, Hangzhou, Shanghai, Beijing, Guangzhou and Boston (USA).

The state-owned holding company Shiva Medical Groupe was presented by Han Feifei, head of the department of the operational engineering center. The company is engaged in the design of pharmaceutical production, construction, solutions in the field of compliance with quality standards, provision of key equipment.

At the end of the business program, the Forum participants communicated in the format of B2B meetings aimed at establishing contacts and initiating new projects between Russia and China.

SuXiaodong, CEOof Chengdu Yingde Biological Pharmaceutical Equipment & Technology

"The development of biopharmaceuticals today is associated with the rapid development of technology. Often, the production of new biopharmaceutical products requires non-standard equipment, which is created, among other things, under an individual order. Efficient and reliable bioreactors, modular equipment, centrifuges are very much in demand in modern production, which produces products according to GMP standards. Russian biopharmaceutical companies today are interested in equipment for the production of vaccines, recombinant proteins, biologically active substances. In addition to the supply of equipment, interest may lie in the transfer of technology from China and factory solutions "turnkey", including design and installation. The complete solutions offered by Chengdu Yingde Biological will allow partner companies to quickly implement construction and reach a given capacity level in the shortest possible time. To date, our company has already established contacts with Russian colleagues, and is open to new contacts. In the future, we can create joint Russian-Chinese pharmaceutical enterprises, which will develop innovative original medicines. This forum was the first for us in Russia, and the positive effect that it gave convinces us of the need to participate in other similar events."

Xu Qiang, Deputy General Manager, ShenzhenWeiguangBiologicalProducts

"At the moment, we are developing two new drugs – RRS and factor VIII. Recombinant coagulation factor VIII is one of the most difficult for the industrial production of proteins, while the modern view of hemophilia therapy involves an increase in the production of such drugs, with increasing requirements for quality and safety. Today it is one of the most important medicines used in hemophilia, but its availability is limited due to its high price. Our company engaged in this development in order to create its own analogue of the drug factor VIII, available to patients in China. The production of the drug RRS is aimed at reducing the cost of blood plasma in the production of drugs and increasing the availability of drug care. Both drugs are in the final stages of research, and within 12 months will have to enter the market. This forum allowed us not only to tell about our activities to Our Russian colleagues, but also to discover the prospects for cooperation to which Shenzhen Weiguang Biological Products aspires. The policy of our two countries provides many opportunities for the exchange of experience and scientific cooperation, including in the field of biopharmaceuticals."

Fan Kai, CEO of PEG-BIO BiopharmCompany

"Our company is engaged in the development of drugs related to metabolism, digestive and endocrine systems. In particular, PEG-BIO Biopharm has its own original developments of insulin of 2 and 3 generations, which are available in the Chinese market. These are insulins of medium duration of action and long-acting. Of course, with a disease such as diabetes mellitus, insulin injections remain indispensable, and new developments are designed to improve the characteristics of drugs and improve the quality of life of patients. We studied the Russian market, and came to the conclusion that perhaps our colleagues will be interested in 3rd generation drugs. Possible formats of cooperation in this area are technology transfer and the creation of joint ventures. In the future, we will also work on the development of the 4th generation of drugs. There are good prospects for cooperation between Russia and China in the field of biopharmaceuticals, and this Forum allowed to obtain important information about each other. During the event, we received 2 invitations from Russian colleagues and intend to continue the dialogue."

Wang Yongsheng, Deputy General Manager of JinyuBio-Technolog y

"One of the values of our company is formulated as follows: "Humanism is as valuable as gold, and good entrepreneurship contributes to the development of talents." This approach is close to both us and our Russian colleagues. For the work of any company, good specialists are needed. Within the framework of this Forum, we were able to establish useful contacts with those people with whom our views are close. For example, GMP standards in the creation of medicines in our countries are considered a necessary system of norms and rules that ensure high quality and safety of the production process and final products. JinyuBio-Technology is known in China as the largest manufacturer of veterinary vaccines. The market of veterinary drugs in Russia is also wide, and we would like to study it in order to start cooperation with Russian pharmaceutical manufacturers. The philosophy of our company assumes that any partnership should be honest and mutually beneficial. We are ready to continue the dialogue, as a result of which the most daring and useful plans can be realized."