Innovation in Asia
For biotech companies in emerging nations, the push toward greater innovation in turn enhances established R&D and manufacturing operations. “Innovation is the front-end leader and also enhancer of both R&D and manufacturing,” Helen Chen, a partner with L.E.K. Consulting in Shanghai, told GEN.
“For example, domestic Chinese pharmas who are now more actively engaged in innovative drug research are filling up many preclinical CROs. Efforts to improve formulation are contributing to both process development and manufacturing growth.”
Genor Biopharma, for example, announced in April that it is constructing a cGMP manufacturing facility in Zhangjiang High-Tech Park in Shanghai for production of its own mAb- and protein-based drugs. It will also set up a new drug R&D and quality control center.
“Within this international standard manufacturing facility, Genor could offer high-quality and cost-effective CRO/CMO services to both international and domestic clients from gene expression to clinical materials production,” the firm has said. “The facility will be ready in mid 2011.”
Chen cited two additional examples of Chinese biotechs focused on innovation: Shanghai Celgen Bio-Pharmaceutical and Epitomics. Shanghai Celgen received a new drug registration approval on May 10 for Qiangke, a recombinant human TNF receptor-IgG fusion protein for ankylosing spondylitis. Epitomics, a U.S. mAb company, has a wholly owned subsidiary in Hangzou. The company reported on May 26 that it will use its RabMAb® technology to produce antibodies for Bayer HealthCare’s drug target identification and validation efforts.
Another U.S. company with R&D operations in China is Pfizer. The company decided to shift some of its Groton, CT, research work to Shanghai, where it is setting up its new Pfizer China Research and Development Center.
“What they’re starting to see is, ‘Look, we can do some quality work in China.’ It helps them broaden their base there because it’s a growing market,” Dr. Nevrivy said. “And you can be sure that other pharma companies are talking about it, and things will happen. It is an endorsement for that type of work being done in that country. Whether it’s going to pan out has not been proven.”
Another Asian country, South Korea, is reaping the fruits of long-term investment in R&D at percentages comparable to those in the developed world. Evidence of this is in the commercial success of some home-grown biotechs. Chen cited Celltrion, which plans to introduce biosimilars for breast cancer and rheumatoid arthritis to worldwide markets later this year after a decade of development work.
Chen also noted LG Life Sciences (LGLS), which earlier this year received an exclusive license to manufacture, develop, and commercialize influenza vaccines using U.S.-based Novavax’ recombinant virus-like particle (VLP) technology in South Korea. LGLS agreed to fund clinical development and licensure of influenza VLP vaccines in South Korea and elsewhere as well as construction of a new VLP vaccine manufacturing facility at its Osong campus in South Korea.
Across Asia’s emerging nations, stem cell companies have performed strongly, Dr. Nevrivy said, since they got a head-start with R&D activity at a time when many of their U.S. and European counterparts were awaiting the outcome of domestic controversies over government funding and patentability, respectively, of human embryonic stem cell research; court cases are still ongoing.
Eager to join China, Japan, and Korea among top-tier Asian biotech nations are Taiwan, Singapore, and Malaysia. “They are much smaller countries, however, and are unlikely to reach the absolute volume of the bigger countries,” Chen said.