The recent China Innovative Drug Ecosystem Forum, organized by STA Pharmaceutical, a WuXi AppTec company (WuXi STA), was a resounding success with apt timing following the recent announcements of history-making new drug approvals. These included two innovative drug approvals under the Marketing Authorization Holder (MAH) pilot program, a program which clears the path for global drug innovators to use China based CDMOs to develop drugs for China market.
More than 300 industry leaders, including pharmaceutical leaders, entrepreneurs and media gathered at the forum to exchange spirited discussions on issues ranging from trends and challenges in innovative drug technology and regulatory policies to how to build a worldwide pharmaceutical ecosystem, and expediting the launch of new drugs.
Speakers included Dr. Xiaolin Zhang, CEO at Dizal Pharma; Dr. Zhenping Wu, Senior Vice President, Pharmaceutical Sciences at Hutchinson MediPharma; Dr. George Wu, Vice President, TESARO; Dr. Jin She, Vice President, Discovery, Early Development and Facility, Hua Medicine; Dr. Bo Shan, Vice President, Discovery, Early Development and Facility, Antengene; and Dr. Xiaoyong Fu, Senior Vice President, API Development & Commercialization, WuXi STA.
During the conference, Dr. Zhenping Wu described Hucthison MediPharma’s significant achievement with the recent approval of fruquintinib capsules (Elunate®) for previously treated colorectal cancer, developed in partnership with CDMOs.
The overall agenda covered topics such as “The New Business Model of Multinational Pharmaceutical Companies in China;” “Launching Innovative Oncology Products: A Biopharma Perspective;” “MAH Practice: From Drug Development to Commercial;” “Meeting the Unmet Clinical Needs in China-Global Clinical Trial Partnership and Collaboration;” and “Partnering with CDMOs in a Rapidly Changing Pharmaceutical Environment.”
During the keynote, Dr. Xiaolin Xhang, founder and CEO of Dizal Pharma, shared with the guests the origin of his company, which was established in October 2017 with a novel business model. Through a joint venture between AstraZeneca and China Advanced Manufacturing Fund, Dizal Pharma was created as a world-leading innovative bio-pharmaceutical enterprise. The company focuses on innovative drug exploration, R&D and commercialization. The establishment of Dizal Pharma is a bold new attempt by multinational pharmaceutical companies in China to fully combine the respective advantages of biotech capital and multinational pharmaceutical companies in the development of new drugs. Dr. Zhang also described, in detail, the innovative model supported by the Dizal Pharma team, which has had significant results in less than a year.
“Multinational companies’ success in China depends first and foremost on whether they have a strategy suitable for local market. The second is the need to do practical things, and to maintain their core competitiveness,” Dr. Zhang told the audience. “As a young company like Dizal Pharma, we want our team to be as independent as possible, to reach its full potential, and to actively participate in the fierce global competition for new drug development.”
When speaking about working together to deliver new drugs, Dr. Zhenping Wu of Hutchinson MediPharma gave some history of HMP over the past 16 years, as well as the changes in China’s innovative pharmaceutical industry.
“HMP was founded in Zhangjiang, Shanghai in 2002 with a $30 million investment on new drug development, an incredible venture at the time. But now, the company growth and success prove the vision,” he said. “To date, HMP has invested $500 million and has completed or is in the process of conducting 36 clinical trials involving eight products.”
Dr. Wu then shared the story behind Hutchison’s two firsts: Savolitinib (Volitinib ®) is a new anti-cancer drug developed by HMP. In 2011, HMP and AstraZeneca reached an agreement to jointly develop, approve and sell savolitinib worldwide. It is the first Chinese innovative drug to be out-licensed to a multinational company intended to reach global markets. In September 2018, HMP received approval of fruquintinib capsules (Elunate®) for previously treated colorectal cancer from the National Medical Products Administration of China (“NMPA”) – formerly the China Food and Drug Administration. The approval in China was completed using a priority review and approval process, thereby maximizing the number of potential patients who can benefit from this novel cancer treatment. This is the second innovative drug approval in China supported by WuXi STA since the implementation of the MAH pilot program.
From the perspective of international experts in new drug development, Dr. George Wu of TESARO discussed today’s global pharmaceutical research and development timetable, innovative product costs, and drug development goals. He detailed, from the perspective of new biopharmaceutical companies, how they look for partners around the world to support everything from R&D and production to the CMC global filing, and the successful launch of innovative antineoplastic drugs. He provided valuable insight for innovative pharmaceutical enterprises that are seeking to apply for global approval.
TESARO is an oncology-focused biopharmaceutical company founded in 2010 with headquarters in Boston. Since its establishment, the company has launched two innovative cancer drugs in the United States and the European Union. What is the secret behind this brilliant achievement?
“Our company does not have its own laboratories or factories, so we rely entirely on outside partners to support R&D, production, testing, registration, etc.,” Dr. Wu said. “Over the years, we have insisted on upgrading from a traditional CDMO service agreement to a strategic partnership as a natural extension of our biopharmaceutical company in order to accelerate the successful launch of our products.”
During the forum, Dr. Jin She of Hua Medicine described the road from new drug R&D to commercial production, focusing on the sharing of Hua’s experience under the MAH program.
“MAH style registration system has existed in the western world for many years, so perhaps people do not feel that the reform has a great impact,” Dr. She said. “However the reform with MAH has a very profound influence in China. With the system developed, consistency is established leading to a clearer more organized operation. This will also be beneficial to our entire drug safety and quality management not to mention the formation of an ecosystem. It’s a win-win situation.”
Unmet Clinical Trial Needs
While discussing addressing the unment clinical needs in China-global clinical trial parternership and collaboration, Dr. Bo Shan, Vice President, Discovery, Early Development and Facility, Antengene, showcased in an in-depth analysis of the NMPA’s new policy, with which foreign clinical data can be accepted and can then be used to design Chinese clinical trials. The combination with foreign clinical trials allows for simultaneous approval in China and the United States.
Antengene is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to tackle unmet medical needs in Asia. This past July, Antengene announced a strategic partnership with WuXi STA for the CMC development and manufacturing of innovative oncology drugs. Under the terms of the collaboration, WuXi STA will provide Antengene an integrated solution in process R&D and manufacturing. WuXi STA was chosen as the strategic partner thanks to its industry leading “end-to-end” CMC platform for new drug development from preclinical to commercial – for both API and finished dosage forms – as well as its expertise and track record for meeting global quality standards.
Partnering with CDMOs
As the sponsor of the forum, Dr. Xiaoyong Fu, Senior Vice President, API Development & Commercialization at WuXi STA, shared a series of cases with colleagues in working with the MAH system at different stages of drug research and development. He showed how to work closely with global customers to help them optimize pharmaceutical technology, reduce production costs, control risks, and improve operational efficiency by using their deep technological accumulation and R&D capability.
“As a CDMO leader, we have always been committed to being a high-quality integrated platform working with each customer for tailor-made solution optimization,” Dr. Fu said in relation to the latest trends in today’s pharmaceutical industry.
The panel discussion, joined by all speakers, was hosted by Dr. Steve Yang, Executive Vice President and Chief Business Officer of WuXi AppTec. Panelists reviewed the implications of developing in-licensed new drugs, as well as how CDMOs can leverage their own technologies to accelerate partners to launch new drugs globally.
“We are grateful for the great era in which all kinds of disruptive technologies continue to emerge, giving developers more ways to target more and more diseases,” Dr. Yang said. “We are more grateful to our customers, your innovative needs and strict requirements which pushes us to continue to promote the practice of internal work, enhance capacity, expand the platform, enabling innovation and prosperity of the industry ecosystem.”
Concluding the forum, Dr. Minzhang Chen, CEO of WuXi STA, added, “WuXi STA has enabled more than 240 customers to develop hundreds of new molecules globally since it was founded in 2004. In recent years, WuXi STA has created a cooperative environment in the process of innovative drug reform in China. It is an achievement we are particularly proud of, as we want to help enable our partners by providing access to new technologies that will accelerate the improvement of patient’s lives.”
Watch for a third China Innovative Drug Ecosystem Forum to be announced for 2019. Follow us on LinkedIn at https://www.linkedin.com/company/sta-pharmaceutical/ .