Hutchison MediPharma (China) has initiated a China-based Phase III study (FALUCA) of fruquintinib (HMPL-013) targeting non-squamous non-small cell lung cancer (NSCLC), reflecting growing pharmaceutical innovation in the world's second-largest pharmaceutical market.
IHS Life Sciences perspective | |
Implications | Chi-Med's announcement comes as China's government exhorts the country's generics-dominated pharmaceutical sector to improve manufacturing standards, and self-audit clinical-trial data, as the sector becomes increasingly prominent in the global value chain. |
Outlook | China's rising healthcare and pharmaceutical innovation is expected to grow, particularly given recent favourable policies – although factors such as slowing economic growth and regional competition are also expected to pose challenges. |
Hutchison MediPharma, a unit of Hutchison China MediTech (Chi-Med, China) has initiated a China-based Phase III study (FALUCA) of fruquintinib (HMPL-013) targeting non-squamous non-small cell lung cancer (NSCLC), reflecting growing pharmaceutical innovation in the world's second-largest pharmaceutical market.
The primary endpoint of the Phase III clinical trial – which is investigating fruquintinib as a third-line treatment for advanced non-squamous NSCLC – will be overall survival (OS). This follows Chi-Med's announcement in September that fruquintinib met the primary endpoint of progression-free survival (PFS) in a Phase II study targeting NSCLC (see China: 3 September 2015: Hutchison China Meditech states fruquintinib achieved primary endpoint in limited trial). Chi-Med expects top-line results from the Phase III clinical trial in 2017.
Chi-Med is additionally awaiting results, due next year, from a Phase III study of fruquintinib as a third-line treatment for metastatic colorectal cancer (mCRC). The molecule – which selectively inhibits the tyrosine kinase activity associated with VEGF receptors – is being investigated for patients with locally advanced or metastatic CRC, who have failed at least two prior systemic anti-neoplastic therapies, including fluoropyrimidine, oxaliplatin, and irinotecan.
Chi-Med's announcement comes as China's government exhorts its generics-dominated pharmaceutical sector to improve manufacturing standards and self-audit clinical-trial data, as the sector becomes increasingly prominent in the global value chain (see China: 28 July 2015: China's FDA launches campaign forcing pharmaceutical companies to self-audit clinical trial data). Consequently, a number of smaller, but well-funded pharmaceutical, biotech, and healthcare players are establishing increasingly innovative pipelines and products – rather than copied products – to compete within global markets.
A significant example is genetic-sequencing company BGI (China), which is focusing on the construction of an immense DNA catalogue from millions of individuals to be utilised in fuelling new drug discoveries. Backed by private equity, BGI benefits from the type of (international) funding which lends the company a certain degree of freedom in its commercial pursuits. Although this may not appear to be significant, BGI – similarly to another rare Chinese brand to gain worldwide recognition, Lenovo – originated as part of a state institution (the Chinese Academy of Sciences), a factor which can often result in underlying influence from the central authorities.
Concurrently, an increasing number of Chinese firms are entering into licensing deals with multinational pharmaceutical companies on innovative treatments, including BeiGene (China)'s oncology-related partnerships with Merck KGaA (Germany).
Outlook and implications
China's rising healthcare and pharmaceutical innovation is expected to grow, particularly given recent favourable policies. Notable among these is the decision, made early in December 2015, to facilitate marketing approval for innovative therapies targeting "major diseases" (see China: 2 December 2015: China to speed up approvals for innovative drugs as pharmaceutical-sector growth slows). In addition, China's State Council stated last month that it will launch a pilot scheme to allow research and development (R&D)-focused bodies to apply for marketing approval for new drugs through a separate process than for manufacturing licences, in order to stimulate innovation in the pharmaceutical sector (see China: 6 November 2015: China launches pilot scheme to facilitate new drug approvals).
Although China's authorities appear to be seeking to spur increased R&D on a regulatory level, additional factors are expected to present challenges – including China's slowing economic growth, and regional competition. Although firms such as Chi-Med and BGI benefit from deep pockets – particularly with Chi-Med indirectly backed by Hutchison Whampoa (Hong Kong) – other R&D-focused companies are less likely to enjoy comparable financial support to drive research, with smaller companies' prospects typically dependent upon successful clinical-trial results. In addition, with fewer regional markets open to non-profit-generating companies (Shanghai and Hong Kong's stock exchanges require a minimum number of profit-generating years), funding options are more restricted.
Furthermore, although China has surpassed Japan as the world's second-largest pharmaceutical market, Japan has in recent years significantly re-oriented its regulatory landscape to foster innovation, particularly in regenerative treatments. While this has effectively placed Japan in a world-leading position, and drawn increasing international investment, China's regulations remain opaque by comparison.