The race for new drug creation is a race between the new and the old, and it is also a race against the impermanence of life with a new order. The creators of new drugs have been playing a game of breakthrough for several years. At present, there are many Chinese companies in the ranks of these successful passers. From the R&D end, production end, business model side, and policy side, China's new drugs are moving towards an unprecedented new situation.

Domestic innovative drug companies sit at the "card table" and turn from spectators to participants. Looking back and looking to the future, this moment can be called the most suitable node.

On December 6, the "2024 Biomedical Conference" was held in Chengdu under the guidance of Chengdu Media Group, sponsored by National Business Daily, and supported by Sichuan Pharmaceutical Industry Association. With the theme of "Decoding the Road of China's Pharmaceutical Reform", this year's Biomedicine Conference brought together well-known scholars, entrepreneurs and representatives of associations in the field of biomedicine at home and abroad. The guests at the meeting analyzed the current situation and challenges of China's biopharmaceutical industry from multiple dimensions, and jointly discussed new opportunities for high-quality development.

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biomedical industry has changed from "existing" to "excellent" China has become a major country in biomedical innovation

At the meeting, Geng Funeng, President of Sichuan Pharmaceutical Industry Association and Chairman of Good Doctor Group, said in his speech that biomedicine is a strategic emerging industry supported by the state, which is not only an important field for the development of new quality productivity, but also an important cornerstone for the realization of the national strategy. At present, China's biopharmaceutical industry is going through the process of changing from "existing" to "excellent", and has established a complete biopharmaceutical industry chain system, with large-scale production capacity ranking among the top in the world.

Geng Funeng, President of Sichuan Pharmaceutical Industry Association and Chairman of Good Doctor Group Image source: provided by the organizer

In recent years, the strength of domestic innovative drugs has gradually been recognized by the international market, and it has become a mainstream phenomenon for MNCs (multinational pharmaceutical companies) to spend real money to seek good "seeds" in the Chinese market. Among them, Sichuan pharmaceutical company Baili Tianheng (SH688506) has made a name for itself due to the potential transaction of ADC (antibody drug conjugate) licensing deal with a total value of 8.4 billion US dollars. At the meeting, Zhu Yi, chairman and general manager of Baili Tianheng, brought a special sharing. He said that the country's payment for innovative drugs currently mainly depends on basic medical insurance, but recently the state has introduced many policies to promote the development of commercial medical insurance, and I believe that commercial medical insurance will definitely bring great help to the development of innovative drugs in the future.

Talking about Baili Tianhengshi, Zhu Yi said, "At the end of last year, we reached a global strategic licensing and cooperation transaction with Bristol-Myers Squibb (BMS) for the largest total transaction value of a single asset in the global ADC field to date. So I think that as long as we keep innovating and work hard, there is still hope that we can achieve what we deserve."

As an important part of new drug research and development, clinical research can be said to be the "door of life and death" to test products and enterprises. At the meeting, Wang Yongsheng, director of the Key Laboratory of Clinical Research and Evaluation of Innovative Drugs of the State Food and Drug Administration and chief health expert of Sichuan Province, gave a keynote speech entitled "Challenges and Thoughts on Innovative Drug Development and Clinical Research from the Perspective of Clinical PI".

Wang Yongsheng mentioned in his sharing that the involvement of PI (principal investigator) is crucial in the business development process from preclinical to phase IV. When looking for PIs, start-ups are especially looking for researchers who are passionate and familiar with the field.

The relationship between clinical research and drug marketing is inseparable, and in terms of drugs and devices, in recent years, many scientific research achievements of universities and institutions have been commercialized, and they have achieved follow-up or even overtaking in specific fields. Wang Yunbing, Dean of the School of Biomedical Engineering of Sichuan University and Director of the National Research Center for Biomedical Materials Engineering Technology, shared the achievements of himself and his team in degradable materials for congenital heart disease.

In August this year, Wang Yunbing's team, together with Pan Xiangbin's team from Fuwai Hospital of the Chinese Academy of Medical Sciences and medical enterprises, broke through a number of key problems, and the degradable atrial septal defect occluder developed by the State Food and Drug Administration was officially approved by the State Food and Drug Administration. "This technological innovation is not a domestic substitution, but the first and only product officially approved for marketing in the world." Wang Yunbing said.

Whether it's learning lessons or gaining insight into trends, the important role of data is self-evident. At the meeting, Zhou Liyun, chairman of the pharmaceutical cube, brought a number of important data in the biomedical industry. He said that judging from the data, the contribution rate of China's new drug pipeline in the global new drug pipeline has reached 36%, indicating that China is already a big country of innovation, and it is also conceivable that the world's innovative drugs will mainly come from the United States and China in the future. In this sense, it took China almost 10 years to complete the path that other developed countries took decades to complete.

What do regulatory experts in the mature pharmaceutical market think about China's innovative strength? Patricia Keegan, Chief Medical Officer of Junshi Biosciences, is also the former Deputy Director of the U.S. Food and Drug Administration's (FDA) Oncology Center of Excellence. Dr. Keegan highlighted the key role that companies can play in driving innovative drug discovery and global market access by appropriately selecting a single region or an international multicenter clinical trial (MRCT). "MRCT can present many potential opportunities, such as the possibility of multiple countries being approved at the same time based on a single trial. However, MRCT also faces challenges in terms of cost and start-up efficiency, [so] for specific diseases, companies can also choose a single-region clinical strategy after full communication with regulatory agencies. ”

"Touching the New Heights of Biomedicine" The top ten innovative cases of biotechnology in 2024 were grandly announced

In the roundtable dialogue session, Wang Yaning, founder and CEO of Shanghai Ruiningkang Biomedical Technology Development Co., Ltd. and former director of the quantitative pharmacology review department of the FDA, Zhang Peng, co-founder and senior vice president of Akeso Biopharma (HK09926), Feng Yi, deputy general manager and chief strategy officer of Kelunbotai (HK06990), and Cai Zhenya, deputy general manager of Yaoyeesco (SZ300937), discussed "touching the new height of biomedicine".

Roundtable dialogue Image source: provided by the organizer

Wang Yaning shared his own experience that at present, China's pharmaceutical R&D is catching up rapidly. On the enterprise side, the proportion of truly innovative drugs in China and the proportion of innovative drugs that can enter the forefront have increased significantly. In his view, the "China speed" shown by the Center for Drug Evaluation (CDE) of the National Medical Products Administration has surpassed that of other countries and regions in some areas. However, Wang Yaning also said that there are indeed some problems in the market, including that capital cannot see the exit channel, so it has reduced investment in the pharmaceutical field, resulting in small and medium-sized enterprises selling their "green seedling" products.

As ivoximab defeated Drug K in the "head-to-head" trial, Akeso has jumped to the first echelon of domestic innovative drug companies. Regarding the future R&D and innovation direction in the biomedical field, Zhang Peng said that at present, ADCs, bispecific antibodies, and triclonal antibodies will still be relatively hot spots in the next few years. In addition, combination therapy is also a major direction in the future. He also mentioned that the direction of R&D investment of international pharmaceutical companies is still worth paying attention to. At the same time, real innovation should be drugs that take into account the gaps in clinical treatment, "as long as we can grasp the direction of innovative drugs and do something truly innovative, we are still very confident."

Because of a series of ADC drug licensing transactions with Merck, the innovative results achieved by Columbus have also attracted the attention of the industry. In the roundtable session, Feng Yi mentioned that the research and development of innovative drugs requires time and capital precipitation, especially the stability of industrial policies is crucial to the long-term development of enterprises. He hopes that the government will introduce sustained, focused policies that have the ability to navigate economic cycles to support the long-term development of enterprises in the research and development of innovative drugs.

After the roundtable session, the "Top Ten Innovation Cases of Biotechnology in 2024" was grandly announced. After the review and screening of multiple links such as open solicitation, big data screening + manual review, and expert review, 10 high-profile biotechnology innovation cases stood out. The selection of "Top Ten Innovation Cases of Biotechnology in 2024" is committed to exploring outstanding innovation cases in the industry and finding real "innovative actors".

Top 10 Innovation Cases Award Scene Image source: provided by the organizer

To create means to open up an unprecedented path, or someone to walk all the way, or someone to wave goodbye halfway. In the past ten years, the story of the collapse is not uncommon, but the victory of a few is inspiring enough. Standing in the present, we knock on the door of the future of biomedicine, open a new realm of exploration, and strive for the ultimate victory.

Cover image source: Courtesy of the organizer