"How many biopharmaceutical companies have been nurtured by this platform? How is the financing situation? Is it profitable?" Walking into a corner of Zhangjiang Medicine Valley, several Shanghai Municipal People's Congress representatives asked the founder about the business of "Dart Accelerator" with great interest model and profitability.
On July 19, the Standing Committee of the Municipal People's Congress conducted a law enforcement inspection on the "Regulations on Promoting the Construction of Zhangjiang Biomedical Industry Innovation Highland in Pudong New Area, Shanghai". After this Pudong New Area regulation comes into effect on January 1, 2022, how do companies in Zhangjiang Pharmaceutical Valley feel about it? The
Dart Innovation R&D Center is one of the stops in this law enforcement inspection. This entrepreneurial incubator originated in Boston, USA. It has now completed the ecological construction and cluster cultivation of the entire process from early drug discovery to preclinical research in the field of biomedical innovation. It has attracted more than 150 high-quality start-up companies and teams at home and abroad, including Gaoji Biotechnology, Shazhi Biotechnology, Fanenshi, and Shenji Changhua, and has considerable influence in the industry.
"Being an incubator is not simply building a house. When we ask about the profit model, we don't just look at how much revenue it makes in a year. We are more concerned about how many projects can be hatched on this platform and how many of these projects can enter the drug application stage. , successfully listed," said Wen Bin, deputy director of the Municipal People's Congress and deputy director of the R&D Management Center of Shanghai Pharmaceutical Group Co., Ltd.
This is exactly what the representatives want to ask during this law enforcement inspection: After the fertile soil of the system is established, how to further stimulate the innovation vitality of pharmaceutical companies?
We are the beneficiaries of this regulation
Biomedicine involves many strong regulatory authorities such as customs, drug administration, and medical insurance. Many pharmaceutical companies “cannot afford to wait” due to the numerous approvals for the import and export of special items.
At the law enforcement inspection symposium, many pharmaceutical company representatives praised the "whitelist system."
In July 2020, Pudong piloted a whitelist system for the entry of special biomedical items, simplifying the import approval process for special items and shortening the time limit for import approval of low-risk special items. This pilot was "solidified" into Article 15 of the Biomedical Regulations - establishing a joint entry-exit supervision mechanism for special biomedical items such as microorganisms, human tissues, and biological products and a joint promotion mechanism for research and development items.
Medicilon, which provides one-stop new drug research and development services to global pharmaceutical companies, "Our company imports hundreds of special items every year. After applying for the whitelist, our application procedures have been greatly simplified, and the approval speed is faster than before. This saves at least half the time," said Yuan Jie, manager of the import and export department of Shanghai Medicilon Biopharmaceutical Co., Ltd. This not only clears up the entry barriers that customers have previously been worried about, but also provides strong support for companies to expand into the international market. .
Haihe Pharmaceuticals, founded in 2010, is an anti-tumor company integrating clinical research and development, production and commercialization. It will obtain a production license in 2021, and its first product will be approved for marketing in 2023. “Whether it is a production license , or on-site inspection, we all passed the approval quickly. From smooth inspection to smooth certification, we are the beneficiaries of this regulation. "
Leboco has R&D institutions in more than 100 countries around the world," we are. The first batch of companies to participate in the whitelist of special items. This efficient and innovative measure avoids communication costs between company departments and provides effective support for our new drug development business.”
Hearing the voices of these pharmaceutical companies, the Pudong New Area Judicial Bureau. Deputy Director Jia Li was deeply touched: "In order to implement Article 15 smoothly, several committees and offices in Pudong New Area repeatedly communicated and coordinated with Shanghai Customs, and finally introduced management measures in the name of the district government, making this policy truly implemented." Jia Li Li said frankly: "In fact, this process is very difficult, but after listening to everyone's speeches today, I feel that the efforts made by our government departments are worth it, because it has been recognized by market entities."
How is the financing difficulty? Solution
"Our new drug lametinib is the first mek inhibitor independently developed in my country. It was launched in March this year, entered Huhuibao in April, and was included in the recommended catalog of innovative pharmaceutical and device products in Pudong New Area in May." Li from Kezhou Drug Lu said, “The implementation of the regulations has greatly accelerated the registration and marketing process of our new drugs."
And the company once encountered a development bottleneck, "Last year's capital winter, our company also encountered financing difficulties. Fortunately, we received support from Pudong Venture Capital and other two major government funds in the new area, which eased our financial pressure. " Li Lu said.
The biopharmaceutical industry is a field where technology, capital, and talents are highly concentrated. It takes an average of ten years for a new drug to be launched from research and development to launch, requiring hundreds of millions or billions of investment. Many companies have experienced " "Narrow escape", suffering from "funding" difficulties.
"If the product is not profitable, there will be no IPO. Without IPO, there will be no profit. Therefore, if the business channel is not smooth, the industrial channel does not exist, and the innovation channel is incomplete. Wu Jianying, deputy to the Municipal People’s Congress and co-founder, president and executive director of Shanghai Haohai Biotechnology Co., Ltd., believes that the construction of the innovation chain of biomedicine is very important. “Capital seeks interests, scientists pursue innovation, and the government focuses on industry. These three demands are To unify. "
The relevant person in charge of the government department at the scene brought good news. At present, Shanghai has established fund of funds for three leading industries. The biomedical industry fund of funds will soon be launched. Through the fund of funds, more social capital will be leveraged to provide innovative pharmaceutical companies. To quench the thirst for funds.
“It is not enough to be driven by municipal funds, we also need supporting services in all aspects. "According to Cao Qingqing, deputy to the Municipal People's Congress and deputy director of the Municipal Economic and Information Technology Commission's Coordination Office for Promoting the Development of Small and Medium-sized Enterprises, most innovative pharmaceutical companies have to "sharpen their swords for ten years," or even longer. In this long process, innovators are needed. The long-term success and the patient holding of capital are also inseparable from the support of supporting measures.
In Cao Qingqing’s view, the legislative goal of this Pudong New Area regulation is to cultivate a world-class biopharmaceutical industry cluster, and world-class biopharmaceutical industry clusters. An industrial cluster must have the support and traction of world-class enterprises. "It is recommended to study the growth pattern of the development of the biopharmaceutical industry to see which links of our services are still lacking and which links need to be strengthened, so as to cultivate fertile ground for innovation and cultivate More first-class pharmaceutical companies. "
