Opportunities for MA-based life sciences companies to partner with or receive investments from Chinese companies are abounding. Yet, there are still concerns around working within the Chinese marketplace and many companies don't know how to begin vetting a Chinese partner. Ahead of our forum on the topic, “Doing Business With China: Changing regulatory reforms and BD opportunities in China,” we spoke with Kate Haviland, Chief Business Officer at Blueprint Medicines, on her experiences partnering with a Chinese company.
Background:
In June, Blueprint Medicines entered into an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of its investigational precision therapies avapritinib, BLU-554 and BLU-667 in Mainland China, Hong Kong, Macau and Taiwan, either as monotherapies or combination therapies.
Why did you decide to pursue a partnership in China now?
At Blueprint Medicines we decided to pursue a collaboration in Greater China because of the significant needs of patients in the region, combined with the important regulatory and economic reform underway. We have been keeping an eye on these reforms as they were announced, including more transparent and straightforward regulatory guidelines. These include the Priority Review program to accelerate drug approvals and a more formal reimbursement process for innovative drugs. As we watched these reforms begin to take effect, it became clear to us there was a significant opportunity to expand our global development across Blueprint’s portfolio of innovative investigational precision therapies to patients in China sooner than we originally anticipated. An example of this is the expansion of the BLU-554 clinical development program in China, where more than half of all new cases of hepatocellular carcinoma (HCC) worldwide occur each year. We recently announced submission of an IND application for BLU-554 under our collaboration with CStone which we anticipate will expedite the BLU-554 program globally. Overall, this was the right time for us to find a partner in Greater China, and we believe our collaboration with CStone Pharmaceuticals puts Blueprint at the forefront of one of the most rapidly growing areas of the global life sciences market over the next decade.
How did you choose who to partner with? What did they have to offer?
We spent over a year meeting with numerous China-based biotech and pharma companies, getting to know their teams, history and views on how to grow their business. These companies were impressive in their own right and also quite different from each other, spanning the more traditional large domestic companies who have been selling drugs for decades, to the new generation of smaller China-focused biotech companies that have recently emerged. We focused on three criteria as we evaluated potential partners. The first was the team. We were looking to work with seasoned executives with deep global experience and regional expertise. The second was the potential to combine our portfolio with potentially complementary cancer therapeutics in a partner’s pipeline. The third criterion was alignment between our two companies’ strategic approach and values. Although this is less tangible, it was critically important to us that the two companies have an aligned long-term vision and a similar approach to achieving our goals. This is important in all collaborations but given the cultural differences and our geographically dispersed teams we felt it was particularly important for us to unite around a common purpose with a potential partner in China. In CStone, we found a partner who fulfilled all these criteria including an impressive team of successful drug development and business professionals, a growing portfolio of potentially complementary cancer [Anchor] therapies with which to explore possible combination treatment approaches, and a sense of urgency to bringing innovative therapies to patients in Greater China and globally.
What concerns, or risks should biopharma companies be aware of when partnering with Chinese companies?
I would highlight two key areas of risk that we spent a significant amount of time considering as we pursued a partnership in China. The first is the timing and definition of the operational details related to implementation of the announced regulatory reforms, and the second is the dynamic created by the increasing volume of capital investment in the region.
On the first area of risk, the trends we are seeing on announced government regulatory reforms are highly encouraging, but it is still early days. The details and timeline on the implementation of many of these reforms are still unclear. We have been living this in real-time as we worked with CStone to submit our first IND application in China. The second area of risk is the significant amount of capital investment flowing into China’s life science sector coupled with the Hong Kong stock exchange rules changing this year to allow pre-revenue companies to IPO. On the positive side, this capital inflow has fueled the establishment of numerous biotech companies focused on developing and commercializing innovative therapies. On the cautionary side for companies looking to partner their programs, this dynamic has led some of these new companies, as well as the larger established companies, to license innovative assets to drive their value story for investors without a long-term plan to effectively develop the acquired assets in the region. Both risks I have highlighted further reinforce the importance of choosing a strong partner, built by a team with a successful track record of executing, grounded with a clear portfolio strategy where the addition of our programs make sense, and connected with right regional relationships to navigate the promising but still uncertain regulatory landscape.
To hear from Kate directly and to learn more about changing regulatory reforms and BD opportunities in China, register for MassBio's forum today.
About Kate Haviland
Kate is a member of the Executive Leadership Team At Blueprint Medicines responsible for the Business Development, Alliance Management, Corporate Affairs, Commercial Strategy and Operations, New Product Planning, Program Management and Information Technology functions. Blueprint Medicines is a publically traded biopharmaceutical company is a leader in the discovery and development of targeted therapies to treat cancer and rare genetic diseases. Prior to joining Blueprint in 2016, Kate was the Vice President of Oncology and Rare Diseases Leadership at Idera Pharmaceuticals. In this role, she led all aspects of the product development and new product planning strategy for the company’s oncology and rare disease pipeline programs.
Previously, Kate worked at Sarepta Therapeutics as the Head of Commercial Development, at PTC Therapeutics in Commercial Development as the product lead for Translarna, and at Genzyme in Corporate Development, before moving into Program Management for two enzyme replacement therapies in the Personalized Genetic Health Business Unit. Before joining Genzyme, Kate spent five years as a life science strategy consultant. Kate's academic background includes a BA from Wesleyan University with a double major in Biochemistry and Economics and an MBA from Harvard Business School. Kate is a member of the Board of Directors of Fulcrum Therapeutics and on the Corporate Advisory Council for the National Tay-Sachs and Allied Disease Association. Kate is also a member of the inaugural class of Women in Bio’s Boardroom Ready Program, the BioPharma Executive Council and the Harvard Business School Healthcare Alumni Association.