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Recently, with the approval of the National Medical Products Administration, the Class 1 innovative drug CC312 developed by Huihe Biotechnology has initiated phase I clinical trials for the treatment of recurrent/refractory CD19 positive B-cell malignant hematological tumors. This is the first domestically and the third globally approved triple specific antibody drug based on CD28 co stimulatory signals to enter clinical practice.
Speaking of the development history of this new triple antibody drug, Dr. Zhu Huaxing, founder of Huihe Biotechnology, still remembers vividly: "Before 2019, no triple antibody drug was approved for clinical use globally, and some investors couldn't understand CC312. During a critical period of company development, Nokai Xinkang Fund invested 30 million yuan to help us complete Series A financing."
Nokai Xinkang is a venture capital fund initiated by Xinze Entrepreneurship Incubator. This incubator, which has been deeply rooted in Zhangjiang Science City for many years, not only invests in Huihe Biology, but also helps the company grow through various "software services", promoting the clinical research stage of new anti-cancer drugs.
Class 1 innovative drug CC312 has been approved for clinical trials.
Investing 30 million under unfavorable capital conditions
Zhu Huaxing and Qu Yi, the founder of Xinze Entrepreneurship and Vice Chairman of Shanghai Incubation Industry Association, are siblings who graduated from the School of Life Sciences at Fudan University. "I have known Dr. Zhu for almost 20 years. He started entrepreneurship while pursuing his PhD, and I have been working as a technology enterprise incubator in Zhangjiang since graduation," Qu Yi told reporters. Last September, Zhu Huaxing's Near shore Protein was listed on the Science and Technology Innovation Board, marking a shining moment in his years of entrepreneurial journey.
Near shore protein is a raw material and technology solution supplier in the fields of healthcare and life sciences, with many downstream customers in the industry chain. However, Zhu Huaxing has not stopped at this enterprise because he has a new drug dream and hopes to develop a batch of domestically produced Class 1 innovative drugs. In order to achieve his dream, he founded Huihe Biotechnology at the end of 2015, focusing on the research and development of innovative drugs for tumor immunity.
In 2020, Huihe Biotechnology received an investment of 30 million yuan from Nokai Xinkang Fund, sharing risks and promoting collaborative development with Xinze Entrepreneurship Incubator. At that time, this biotechnology company was not a hot spot in the capital market. Firstly, the company's research on three new antibiotics was relatively advanced in the industry, unlike PD-1 and CAR-T drugs, which were investment hotspots; The second reason is that the founding team of the company is not luxurious enough, neither overseas returnees nor foreign companies.
In this context, Qu Yi decided to invest and also recommended Huihe Biotechnology to other investors, introducing over 50 million yuan in funds. "I know that Senior Brother Zhu has a complex for making innovative drugs, and he has rich entrepreneurial experience. I believe he has the ability to grasp the forefront of biopharmaceutical technology. When investing in a company, the key is to invest in the right people." Qu Yi said of the reasons for his firm investment at that time.
It has been proven that this incubation industry expert has made the right decision. Now, Huihe Biotechnology has established three innovative tumor immune drug development platforms. Among them, the development platform for T cells has nurtured CC312, a candidate new drug that has been approved for phase I clinical trials in China and the United States.
CC312 Structure
Software services connect enterprises, industries, and governments
In addition to investment, Xinze Entrepreneurship Incubator also provides a series of services for incubated enterprises. Dr. Zeng Li, Chief Operating Officer of Huihe Biotechnology, believes that the quality of incubators is mainly reflected not in hardware level, but in software services.
As a light asset biotechnology company, Huihe Biotechnology needs to outsource a lot of research and development work to CRO companies. For this reason, Xinze Entrepreneurial matchmaking facilitated the cooperation between this enterprise and Medici. Biotechnology companies also need to do a good job in intellectual property layout to avoid infringement risks. Xinze Entrepreneurship recommended a terrace consulting company that provides life science intellectual property services to Huihe Biotechnology. As of now, Huihe Biotechnology has applied for 16 invention patents and has basically completed its patent layout in the Chinese and international markets.
Incubators are platforms that connect startups with industrial resources, as well as links between government departments and startups. The R&D subsidy policies, talent policies, tax policies, and qualification applications of Shanghai and Zhangjiang Science City... Xinze Entrepreneurship often transmits this information to incubated enterprises, allowing them to timely learn about various favorable policies and achieve the implementation of technology enterprise support policies.
What remains fresh in Zeng Li's memory is that during the Shanghai epidemic last year, due to the company's inability to replenish essential laboratory operations such as liquid nitrogen and carbon dioxide, he felt quite anxious. The survival of cell lines cultured in the laboratory requires a liquid nitrogen environment at -196 ℃; The cells in the cell chamber cannot survive without carbon dioxide. Once these two essential items are not replenished on time, all cell lines used for antibody production may be lost. After learning about this situation, the Xinze team communicated and coordinated with relevant departments in Zhangjiang multiple times, and finally secured a special admission quota for Huihe Biology, solving the urgent need.
How to develop innovative strategy source functions for incubators
Nowadays, Shanghai is cultivating high-quality incubators. In Zeng Li's view, this government measure is beneficial to the development of the biopharmaceutical industry. In recent years, innovative biotechnology small and medium-sized enterprises have become the main force in new drug research and development. Statistics show that from 2011 to 2020, the US Food and Drug Administration approved a total of 410 new drugs for marketing, of which over 60% of innovative anti-tumor drugs came from Biotech rather than Big Pharma. On the other hand, many biotechnology companies are in incubators, so cultivating high-quality incubators will enable these enterprises to receive better services, more investment, and accelerate innovative drug research and development.
"The government can regularly rate incubators throughout the city." Zeng Li suggested that "incubators rated as excellent not only receive project support, rent subsidies, and other financial incentives, but also recommend innovative enterprises to the government." He explained that compared to government departments, incubators have a deeper understanding of incubated enterprises and a clearer understanding of their technological level and development potential. Therefore, in terms of government support for enterprises, incubators have the ability to play the role of evaluation experts.
The government can also promote the linkage between high-quality incubators, venture capital funds, and banks, allowing incubated enterprises to have more opportunities to obtain venture capital and higher bank loan limits.
Open Innovation Center jointly built by Xinze Entrepreneurship and Biochip Company
Qu Yi believes that incubators should actively participate in technological innovation strategies and provide "advanced incubation" services for scientists in universities and research institutions. "You see, this is a WeChat message sent to me by researcher Chen Hua from the Beijing Institute of Genomics, Chinese Academy of Sciences. His entrepreneurial project won third place in the Zhongguancun International Frontier Science and Technology Innovation Competition, with the first two being academician projects." Qu Yi couldn't conceal his excitement in his words, "I have introduced Chen Hua's team to Xinze, providing 'advanced incubation' services, and striving to push their developed hybrid DNA intelligent analysis system to the market."
The so-called "advanced incubation" refers to providing entrepreneurial guidance and conducting concept validation for entrepreneurial teams before registering a company, mainly to verify the commercial feasibility of entrepreneurial projects. In Qu Yi's view, in the process of cultivating high-quality incubators, Shanghai needs to strengthen the "advanced incubation" function of incubators for research teams in universities and colleges, and transform more cutting-edge scientific and technological achievements into products.
