CRI Report-The driving force for pharmaceutical manufacturing is R&D of new products. According to the 12th Five-Year Plan for Biopharmaceuticals about to be issued, R&D of new drugs will continue being a focus, and the Chinese government will invest over CNY 40 billion in R&D of biopharmaceutical products. At the industrial level, driven by various supporting policies of national industrial upgrading and concentration promotion, China's pharmaceutical industry begins carrying out the resource integration, a batch of R & D-oriented enterprises are gradually expanding, and the growth pattern of “Development Driven by R&D” is also established progressively. The biopharmaceutical field has undoubtedly become the focus in the upsurge of biopharmaceutical R&D.
The future development potential of biopharmaceuticals has been unanimously recognized by domestic and foreign pharmaceutical enterprises, and increasingly more pharmaceutical enterprises are concerned about and setting foot in this field. Statistics show that 200 pharmaceutical manufacturers are engaged in R&D and production of biopharmaceuticals. Simcere, CP Guojian Pharmaceutical, Huasun Group, Jiangsu Hengrui, Biontech Inc., etc. launched biopharmaceutical products long before. Meanwhile, in the upsurge of biopharmaceutical R&D, numerous large domestic pharmaceutical groups are also entering the biopharmaceutical field. It is reported that North China Pharmaceutical Group Corporation, a leading manufacturer of penicillin and cephalosporin, has accelerated R&D of and investment in the biopharmaceutical field.
In addition, Shanghai Pharmaceutical Group will invest CNY 180 million in R&D of 4 biopharmaceuticals jointly with Shanghai Fudan - Zhangjiang Biopharmaceutical in the next 6 years; Livzon Pharmaceutical Group Inc. has been involved in the field of vaccine R&D and production and invested heavily in the establishment of an antibody drug R&D company with its parent company, namely Joincare Pharmaceutical Industry Group Co., Ltd.; Tasly, a leader in the field of traditional Chinese medicines cooperated and established a joint venture with TRANSGENE in France in May, 2010 for the build-up of biopharmaceutical research platform; Shanghai Fosun Pharmaceutical also jointly invested about CNY 500 million in the build-up of monoclonal antibody drug project with CHEMO Group in Argentina in July, 2010. Large pharmaceutical enterprises represented by Shanghai Pharmaceutical, Sinopharm, North China Pharmaceutical undertake the uppermost responsibility of the development of China's pharmaceutical industry. Their involvement in the biopharmaceutical field indicates that the awareness and development orientation of China's pharmaceutical industry has risen to a new level, which is the basis for China to become a pharmaceutical power.
Meanwhile, the upsurge of biopharmaceutical R&D has another evident characteristic that the enterprises' product R&D mode is geared to the international mode, namely the focus is transferred from internal R&D to multi-channel cooperative R&D. Through the specialization of production, teaching and research, product structure transference and growth pattern transformation can be well realized, and time and capital invested originally by a single enterprise or institution will be decomposed into various links. Under the premise of ensured quality, the pressure of time and expenses will be not very heavy in terms of single functional chain, but share the fruits of large-scale production simultaneously. Accordingly, win-win and multi-win are expected to be realized ultimately.
The biopharmaceutical industry is still suffering from declining R&D capability of new drugs. At present, increasingly more new drugs are rejected by FDA (Food and Drug Administration), while the development costs of new drugs present rapid expansion. It is predicted that only an average of 20 – 25 new drugs annually will be approved by FDA in the next 60 years, since the pharmaceutical enterprises focus on the drugs easily to be developed as well as the developed drugs with remarkable effect in the early stage of drug development. As for many new drugs, it is very hard for them to surpass the existing drugs whether in terms of curative effect or safety.
The development of new biopharmaceuticals is increasingly more difficult and the costs of biopharmaceutical R&D are continuously rising. Under the pressure that the product patents of large multinational companies are successively expired, cooperative R&D has become the most common R&D mode of multinational enterprises at present. Besides, in order to obtain new products quickly, biopharmaceutical R&D partners of multinational pharmaceutical enterprises also extend from multinational enterprises to pharmaceutical enterprises in any countries, indicating that the R&D capability of China's pharmaceutical enterprises has been recognized by multinational enterprises and the R&D mode of domestic enterprises are rapidly rising to the level of "international mode". The R&D technology and management strength of domestic pharmaceutical enterprises will be constantly enhanced through the cooperative R&D with multinational pharmaceutical enterprises.