china-biopartners The Top-60 Chinese Biopharma Companies

1 China- biopartners The Top-60 Chinese Biopharma Companies Biopharmaceutical launched another The Evolution of Modern Biotechnology in world's first, a commercial recombinant China Is Continuing at a Rapid Pace human endostatin (Endu) for treatment of non-small-cell lung cancer, which is pro- Eliza Yibing Zhou rank firms. Because growth rates are jected to have the potential to become a important to track, we also used informa- blockbuster in the Chinese market. These E. ighteen years have passed since the tion from the China Biopharma Index , a successful stories showcase Chinese first modern biotech firm, quarterly evaluation of trends and market biotechs' capabilities to perform and com- Shenzhen Kexing biotech , was growth in the Chinese biopharmaceutical mercialize cutting-edge research. inaugurated in China. As China's biotech industry. In China, the biopharmaceutical indus- pioneer, Kexing brought the first Chinese - Noticeably, while the majority of the try has been recognized by the government developed protein therapeutic (recombi- Chinese biotechs are dedicated to the as the most important and most promising nant human interferon 1b) to the market development and commercialization of fol- industry for the 21st century.

2 With a in the early 1990s. Nearly 200 modern low-on biologics, several Chinese biotech healthy 20 25% annual growth rate, and biotech drug firms have followed, and they innovators have launched biotech thera- a diversified pipeline, the Chinese biophar- have launched 35 biotech drugs to the peutics, aimed at the global markets. maceutical industry is moving toward domestic market in recent years. In 2004, Shenzhen Sibiono GeneTech, globalization. According to a newly released study, for example, reportedly commercialized The industry is witnessing a surge of Top 60 Chinese -owned the world's first gene therapy product, mergers, acquisitions, and partnerships Biopharmaceutical Companies published recombinant human adenovirus-p53 injec- between national big pharmas and small by BioPlan Associates ( tion under the brand name of Gendicine. biopharmas, as big pharmas are actively ), with the further expansion of The company reports that Gendicine has looking to broaden their product portfolio the Chinese biotech sector, a growing num- been shown to be beneficial in the treat- with biotech therapeutics.

3 Furthermore, ber of innovation-focused biopharmaceuti- ment of over 40 kinds of solid tumors and big Chinese CMOs are lauching biophar- cal Companies are emerging. is safe and effective based on clinical ma businesses by teaming up with interna- To gauge this expansion, we first results from thousands of cancer patients tional biotech giants such as the partner- engaged in benchmarking and a reason- worldwide. ship between Zhejiang Hisun Pharma and able ranking exercise of the existing com- A further breakthrough in gene therapy Amgen. panies in China. We believe this project, was achieved in November 2005 when Some startup CMOs, like AutekBio, which required in-depth analysis of the China's State Food and Drug based in both Beijing and Santa Clara, CA, performance indicators of the Top-60 Administration (SFDA) approved recombi- have shown potential by receiving con- Chinese -owned Biopharma firms, is the nant human adenovirus type 5 injection tracts for development of mAbs.

4 First study of its kind. (Oncorine or H101) for the treatment of Although operation costs have increased This project required thorough analysis patients with late-stage refractory nasopha- with the value of the Chinese currency, the of the Companies involved in development ryngeal cancer in combination with enthusiasm for Western biopharmas seek- and commercialization of recombinant chemotherapy. ing outsourcing partners in China has not proteins, monoclonal antibodies (mAbs) Developed by Shanghai Sunway biotech , diminished. and vaccines. Detailed company profiles, Oncorine, the company claims, is the including hard-to-get official financial and world's first oncolytic viral therapy Vaccine Producers operational data, production capacities, approved by a regulatory agency. In 2006, The first Chinese biotech Companies pipeline products, were used to assess and Shandong Simcere Medgenn were mostly vaccine providers.

5 These Contact: MUST SEND TO ERIC lANGER FOR. REVIEW ONCE PROOFED. 2 GEN galley organizations have a relatively long history viding a research and commercialization Chinese market in 1993 and opened its in China, and because of the domestic base for novel vaccine candidates. first production facility in Tianjin in 1996. healthcare and vaccine needs of the world's Another important state-owned vaccine Novo Nordisk has grown rapidly in China, largest population they tend to be much manufacturer is the Institute of Medical and the company has dominated the larger in size. Biology affiliated with the Chinese human insulin market there for many The earliest traditional vaccine produc- Academy of Medical Sciences. It is the years, with billion RMB ($261 million). er, National Serum and Vaccine Institute largest poliomyelitis vaccine producer in sales in 2006. (NVSI), was founded in 1919.

6 NVSI is cur- China and has provided more than five bil- Another aggressive foreign player is rently one of the nine subsidiaries directly lion doses of polio vaccines to Chinese Sanofi-Pasteur, which set up an influenza controlled by China National Biotec children since the 1960s. The institute is vaccine facility in Shenzhen in 1996. In Group (CNBG). With more than 9,000 also one of the major providers of hepatitis November 2007, the company announced employees and worldwide revenues of A vaccines in China. that it will invest 700 million RMB ($94. $421 million in 2006, CNBG is the largest By comparison, privately owned vaccine million) to expand facilities in Shenzhen, producer of vaccines and blood derivatives manufacturers tend to be small and princi- with the goal of producing seasonal in China, enjoying more than 80% and pally engaged in the production of non- influenza vaccines for the Chinese market 30% domestic market share, respectively.

7 Government-planned vaccines with higher by 2012. This will undoubtedly create CNBG produced over one billion doses profit margins. Major privately owned powerful competition for Chinese influen- of vaccines in 2006 and claims to be producers include Sinovac biotech , za vaccine manufacturers. among the top-10 vaccine manufacturers Changsheng Life Science, Shenzhen GlaxoSmithKline also set up an influenza in the world. Kangtai, Zhejiang Tianyuan, Jiangshu vaccine production facility in Shanghai As a state-owned company, CNBG Yanshen, Liaoning Yisheng, Liaoning Zhangjiang High-tech Park in 2004. plays a critical role in China's National Chengda, Dalian Hassen, and Forwell Immunization Program and has been pro- Biopharma . Changing biotech Environment viding 90% of the country's planned According to the SFDA, Chinese vaccine The Chinese biotech industry has estab- immunization vaccines under the pro- producers have marketed 49 vaccines to lished critical mass and is now aggressively gram with limited profit margin.

8 To date, fight 26 infectious diseases, with over one working to catch up with its foreign com- CNBG has marketed 34 vaccines (mostly billion doses annual output, including 500 petitors from developed countries. The traditional vaccines), 17 hematologic prod- million doses of vaccines against major government has realized the importance of ucts, and over 30 diagnostic agents, prima- infectious diseases such as hepatitis B, biotechnology and has prioritized the rily in the domestic market but has recent- poliomyelitis, measles, pertussis, and diph- biotech industry on its agenda. ly entered international markets through theria. As a result of the work of these tra- China has enticed an abundance of its trading subsidiaries and business part- ditional biotech Companies , China claims high-caliber China-born biotech employees ners. to be the world's largest vaccine manufac- with many years of education, research, Two of CNBG's subsidiaries are prepar- turing country in terms of production and work experience in the West to return ing to obtain WHO prequalification for a scale.

9 To their motherland to set up or take senior Japanese encephalitis vaccine and polyva- positions in Chinese biotech Companies . lent rotavirus vaccine through collabora- Foreign biotech Competition Many Chinese firms are spending exten- tions with PATH. Meanwhile, NVSI, in Since the 1990s, a number of multina- sively for faciltiy expansaion and upgrades partnership with Beijing Tiantin Biologica tional biotech players have established to meet Western GMP standards. Some are Products and the Virology Institute at their presence in China lured by a wealth beginning to import production lines from China Disease Control Center, is working of advantages. The most successful foreign the West. This trend is likely to continue. on establishing a National Engineering biotech player in the Chinese market today The growing number of international Center for Novel Vaccines, aimed at pro- is Novo Nordisk, which entered the biotechs partnering with Chinese compa- 3 GEN galley nies in R&D and production has provided the world's largest destination for import- Innovation and Outsourcing opportunities for Chinese biotechs to gain ed products.

10 These products are becoming management know-how from their increasingly more affordable to Chinese Based on our study of the Top-60 . Western partners. As an emerging biophar- consumers. Chinese Biopharma Companies , we predict maceutical outsourcing hub, China is rap- Some Chinese biosimilar manufacturers that innovation and outsourcing will idly becoming an important cog in multi- with limited knowledge of international IP become major drivers for China's biotech nationals' global strategies. law may be faced with potential IP con- industry over the next 5 10 years. At pres- In the early 2000s, Western Companies flicts or lawsuits from foreign Companies ; ent, the potential for Chinese biotechs to tended to look to China for cheap labor this may impact global market plans. become competitive in the global market and raw materials. Today, what makes Other challenges facing Chinese biotechs has not yet been realized.