With the implementation of the MAH system in China’s pharmaceutical industry, MAH investments have become a hot topic. MAH stands for Marketing Authorization Holder, which separates marketing authorization from manufacturing authorization under the new drug registration system. This allows pharmaceutical companies to focus more on drug R&D and commercialization while outsourcing manufacturing to partner factories. As a result, many companies are making strategic MAH investments to capitalize on this policy change. In this article, we will provide an overview of MAH investments in China’s pharmaceutical industry.
Opportunities for MAH Investments
The MAH system creates many new opportunities for investments. Firstly, companies can invest in acquiring MAH qualifications to gain marketing rights for new drugs. Secondly, investments can be made in R&D for innovative drugs and biologics to obtain future MAH rights. Thirdly, investments in CROs and CDMOs to support outsourced manufacturing are also key areas. Additionally, companies are making MAH investments to build new business models around MAH commercialization and platform technologies.
Key Players Making MAH Investments
Major pharmaceutical companies like Fosun Pharma, WuXi AppTec, Hansoh Pharma have made significant MAH investments lately. Fosun obtained MAH rights for codrituzumab through collaboration with Biogen. WuXi STA invested in R&D and testing to gain MAH rights for some drugs. Hansoh Pharma also invested heavily in an R&D center to develop MAH products. Besides large companies, many biotech startups have also received MAH investments from VCs and PE funds to grow their pipelines.
Challenges and Risks for MAH Investments
While the MAH system brings opportunities, there are also challenges and risks involved. The fragmented production environment with many small factories increases oversight costs. Long development cycles for innovative drugs also delay investment returns. Policy uncertainty around pricing and reimbursement makes forecasting difficult. Lastly, there is intense competition in acquiring promising MAH candidates, resulting in high valuations.
Outlook for the Future of MAH Investments
Looking ahead, MAH investments will continue rising as more companies adopt MAH strategies. Consolidation is also expected among CDMOs to improve economies of scale. Regulation will strengthen to improve drug quality assurance. Biologics and innovative therapies will be a key MAH investment area as well. Overall, a favorable policy environment and market demand will drive more MAH investments despite existing challenges.
In summary, MAH investments present major new opportunities under China’s new drug registration system, attracting investment across the pharmaceutical value chain from R&D to manufacturing to commercialization. With appropriate risk management, MAH investments can deliver strong returns for companies seeking to capitalize on this policy change.