XinNews | Meng Ruifeng, CEO of XinBio: The 'lone hero' on the path of domestic substitution in the CGT field
Date：2023-08-26 Views：
In Shanghai Zhangjiang High-tech Park, a reporter from Shanghai Securities News met with Meng Ruifeng, CEO of Suzhou XinBio Co., Ltd. He was wearing a simple white T-shirt and enthusiastically told the reporter about the development of the company and the industry. The CGT (Cell and Gene Therapy) track focused by XinBio is a "cutting-edge" in the field of biomedicine. However, the equipment and consumables in the field heavily rely on importing, thus the road to domestic substitution is long and arduous.
Meng Ruifeng, CEO of XinBio
The innovative path of domestic substitution
In the field of CGT, integrated cell preparation equipment is the mainstream in foreign countries, while distributed equipment is currently dominant in China. XinBio is currently the first domestic manufacturer of fully automated cell preparation machines.
XinBio was established in 2015. At the beginning, the company's main business was trade and OEM of foreign medical device brands. Meng Ruifeng introduced that at that time, 95% of biomedical equipment, reagents, and consumables relied on imports. After foreign suppliers supply, the progress of domestic customers can continue to advance. Since then, Meng Ruifeng has felt the constraints of overseas dominant enterprises on the production activities of domestic enterprises.
Meng Ruifeng gave an example that although equipments can be only purchased once, reagents and consumables need to rely on importers for a long time. It takes more than six months from prepayment to receiving an imported integrated cell preparation machine.
Since 2018, XinBio has been fully focused on the CGT field. On February 21, 2023, the third collective study session of the Political Bureau of the Central Committee proposed that in response to international scientific and technological competition, to achieve high-level self-reliance and self-improvement, we must fight a tough battle for the localization of scientific and technological instruments, operating systems, and basic software. we should improve the level of localization substitution and application scale, and strive to achieve the early use of China's independent research platforms, devices and equipments to solve major basic research problems.
"The central government has elevated the localization and substitution of technological equipment to the national strategic level, which has indeed given us great encouragement and confidence."said Meng Ruifeng.
XinBio's development history
CGT leads industrial transformation
"Cell and gene therapy is known as the fourth revolution in the medical field, with the opportunity to cure cancer patients, "said Meng Ruifeng. XinBio's goal is to become a supplier of the entire CGT tool industry chain.
Meng Ruifeng introduced that CGT is mainly used in malignant tumors, and has many applications in autoimmune diseases and extremely rare diseases. In the future, it may be expanded to the field of big health. "A single treatment may achieve a lifelong cure."
In August 2017, the world's first CAR-T (chimeric antigen receptor T cell) product was launched. CAR-T therapy is one of the therapies for cell and gene therapy. This product is launched by Novartis and is indicated for acute lymphoblastic leukemia. The world's first patient to receive CAR-T cell immunotherapy has zero cancer cells detected in the 11 years since receiving treatment.
According to data provided by Sullivan, Zhiyin Capital, and other institutions, the global CGT market grew from $50 million to $2.08 billion from 2016 to 2020, with a compound annual growth rate of 153%. It is expected that the overall global market size will be $30.54 billion by 2025, and the estimated compound annual growth rate of the global CGT market from 2020 to 2025 is 71%. From 2016 to 2020, the CGT market in China grew from $2 million to $3 million, with a compound annual growth rate of 12%. The overall market size is expected to be $2.59 billion by 2025, and the compound annual growth rate of China's CGT market is estimated to be 276% from 2020 to 2025.
The enormous potential of CGT fieldhas attracted much attention from capital. Meng Ruifeng introduced that there were 116 financing deals in the CGT field in 2022, with a total financing amount of approximately ¥17.913 billion, and a compound annual growth rate of 59.3% from 2016 to 2020.
"Currently, there are three CAR-T drugs on the market in China, namely Fosun Kite's Yikaida®, WuXi Mingju Nuo's Beinuoda®, and Fukusu®, jointly developed and commercialized by Iasobio and Innoventbio." Meng Ruifeng introduced that as of now, nearly 600 patients have used the first two drugs, with sales exceeding 600 million.
Meng Ruifeng introduced the process of using XinBio's fully automated cell manufacturing system to treat patients. Firstly, it is up to the doctor to determine whether CGT medication can be used to treat this patient. After approval by the doctor, the patient's blood is evaluated and extracted as raw material to form a drug according to a specific process, and finally transfused back to the patient. The entire process takes approximately 7-14 days.
The device has different built-in processes, and the company team can modify the processes and develop new applications for free according to customers' personalized needs. At present, this device is used to produce drugs for treating hematoma, and may be expanded to other fields in the future.
Meng Ruifeng introduced that the integrated fully automatic cell preparation equipment has a significant cost reduction and efficiency improvement effect compared to distributed equipment, and can reduce the risk of blood contamination. If distributed devices are used, involving more links, equipment, and personnel, the probability of raw material contamination will increase.
"XinBio hopes to develop its own antibody development technology." said Meng Ruifeng." Overseas companies' antibody development is based on mouse sources, while XinBio's antibody development is based on human sources. All employees of the company are involved, and their genes are used for extraction, analysis, and database construction. The human pathway can avoid antigen antibody reactions, and antigen antibody can have better binding effects.
XinBio automated cell manufacturing system
Hold on, wait for the market to explode
"I hold a cautious and optimistic attitude towards the CGT market, and it will take 5-10 years for the market to explode. If cautious, it will take 10 years, and if optimistic, it will take 5 years. "Meng Ruifeng told reporters that the fully automatic cell preparation machine is facing the dilemma of insufficient demand and the market has not yet exploded in China.
There are two sales channels for cell preparation machines: one is for pharmaceutical companies to produce drugs directly for clinical doctors to use; Secondly, qualified A-Class hospitals provide patients with free trial drugs in the form of clinical project research. Pharmaceutical companies tend to choose imported brands with mature technology and existing popularity; However, striving to enter the hospital market is hindered by a lack of clinical evidence.
Meng Ruifeng stated that currently in China, the prices of cell and gene therapy are relatively high and are not included in the reimbursement scope of domestic medical insurance. The fully automated cell preparation machine faces payment challenges in China and is difficult to widely apply.
In 2022, XinBio's revenue is 17 million, and the planned revenue for 2023 is ¥30 million. The majority of the company's revenue is contributed by reagents and consumables. So far, the total investment of the company has exceeded 50 million yuan. "We aim to remain stable next year and achieve profitability the year after." said Meng Ruifeng.
"In the field of cell preparation equipment, the company had 30-40 competitors at the beginning of its establishment, but now there are only three or four left, "said Meng Ruifeng. Many companies have collapsed because the input-output ratio is not cost-effective, and there is no period of market explosion. The process of innovation and entrepreneurship in such a cutting-edge track is very painful. But we have firmly walked a long way, believing that we can see into the distance and into the future.
Currently, XinBio is conducting a Pre-A round of financing. "We have met over a hundred investors. In fact, what we need most is not capital, but industry and market support."said Meng Ruifeng.
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