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Biosion usually retains domestic commercial development rights when cooperating with overseas biotechs, and overseas commercial development rights if the cooperating domestic company has no overseas plans. This partnership model brings Biosion's ability to self-hematopoiesis. In addition, Biosion is also exploring methods such as the spin-off of important assets as a supplement to the license-out.
The TSLP monoclonal antibody bosakitug is Biosion's fastest-growing pipeline and is in Phase 2 clinical trials for atopic dermatitis in the United States. All of the company's projects are derived from the company's three proprietary innovative antibody discovery technology platforms. At the 2024 DJS Innovation Partnership Summit in May, Biosion will be on the roadshow.
Written by | Xu Weijia
Aiolos Bio, which was founded less than a year ago, was successfully acquired by GSK with the only TSLP monoclonal antibody AIO-001 received from Hengrui, with a total transaction price of up to US$1.4 billion. GSK's swift and decisive acquisition without much clinical progress has put the potential of TSLP targets back in the spotlight for the biopharma industry.
As a rising star in the field of autoimmunity, only tezepelumab, a monoclonal antibody jointly developed by Amgen/AstraZeneca, has been approved for marketing. Globally, there have been many entrants such as Novartis, Pfizer, and Sanofi. Among the domestic enterprises, Biosion/Chia Tai Tianqing, Kangnuoya/CSPC Pharmaceutical Group, and Hengrui each have products that have entered the phase 2 clinical stage.
Among them, Boaosion/Chia Tai Tianqing's bosakitug (BSI-045B/TQC2731) is relatively ahead in development progress, and is conducting phase 2 clinical trials for atopic dermatitis in the United States. In the process of exploring the research and development of bosakitug, we found that Biosion, which independently developed the drug molecule, is embarking on a path of innovative development.
Biosion's Chief Strategy Officer, Dr. Xinliang Yip, will represent the company at the 2024 DJS Roadshow, so stay tuned.
A different path from most Chinese biotechs
The partnership between Biosion and CT Tianqing began in 2017. At the time, Biosion was just founded, determined to explore a different path from most Chinese biotech companies: In Global For Global.
In an interview with R&D, Dr. Ye Xinliang, Chief Strategy Officer of Biosion, said: "The company's founder, Dr. Chen Mingjiu, and the entire team have extensive overseas experience. From our point of view, biotech should be global. ”
At present, more and more companies pay attention to going overseas, but most of the "In China For Global" strategy is still based on China's unmet clinical needs, relying on the data of Chinese clinical trials to do license-out.
"Biosion's difference is that all of our assets will take into account the world's unmet clinical needs, with the largest markets in Europe and the U.S. as part of our overall development strategy. In addition, we have been conducting clinical trials overseas from the very beginning to obtain global data. Ye Xinliang said.
Driven by a global perspective, Biosion has chosen two major tracks, autoimmunity and oncology, which are both challenging and promising. Dr. Hugh M. Davis, Chief Commercial Officer and Development Officer, President of the U.S. Branch, has many years of R&D experience in the field of autoimmunity and oncology, which also gives Biosion more confidence in these two tracks.
In the field of autoimmune diseases, Biosion is focused on multiple leading-edge targets. Among them, the TSLP monoclonal antibody bosakitug (BSI-045B/TQC2731) is the company's fastest growing pipeline, which is conducting a phase 2 clinical trial for atopic dermatitis in the United States, and plans to present clinical data at an international conference in June this year.
"It has long been recognized that the main value of TSLP is in asthma indications, and our clinical data will show its potential for atopic dermatitis for the first time. Ye Xinliang said. In addition, Biosion has also deployed TSLP bispecific antibodies to further explore the potential of this target.
In the field of oncology, Biosion has five molecules that have entered Phase 1 clinical trials. These include the recently popular Trop-2 ADC, as well as innovative drug candidates with BIC or FIC potential, such as CD40, PD-1/ILT4, and Siglec-15.
Biosion has offices in China, the U.S. and Australia to support its "In Global For Global" operating model. Nanjing, China, as its global R&D center, undertakes the key aspects of molecular discovery of innovative drugs and the verification of preclinical pharmacological efficacy, while the early clinical center is set up in Australia for Phase 1 clinical trials of the product, and subsequent clinical trials are mainly conducted in the United States. At the same time, the company's BD team across China and the United States jointly promotes global business development.
According to Ye, all of Biosion's assets come from the company's three proprietary platforms: the H³ (high-throughput, high-content, high-efficiency) antibody discovery platform, the SynTracer high-throughput antibody endocytosis screening platform, and the Flexibody bifunctional antibody technology platform.
In fact, since 1998, the founder Chen Mingjiu has accumulated more than 20 years of experience in the research of antibody technology platforms. Compared with some early-stage biotechs, Biosion's technology platform is relatively mature and has been validated in more than a dozen clinical programs.
Is asset carve-out the next breaking point?
In the seven years since its founding, Biosion has built seven clinical assets through its proprietary technology platform and has established a series of innovative drug pipelines with biopharmaceutical companies around the world.
"Once the asset entered the PoC stage, the company began to actively look for the right partner. When cooperating with overseas biotech companies, it usually retains the commercial development rights in China, while with domestic companies, Biosion will retain overseas commercial development rights if the other party has no plans to go overseas. Such a cooperation model can not only empower partners to accelerate the progress of the global clinical development of the innovation pipeline, but also bring a certain amount of revenue and make blood for the company's sustainable innovation. This self-hematopoietic model has helped us resist the downside risk of industry development under the capital winter cycle. Ye Xinliang said.
At present, Biosion has four products that have reached different forms of cooperation with the well-known domestic pharmaceutical company CTTQ, and several oncology products have cooperated with overseas innovative drug companies Pyxis Oncology, Celldex and OBI Pharma. In January, OBI Pharma announced that a Phase 1/2 clinical trial of a next-generation Trop-2 ADC (OBI-992) licensed from Biosion had been approved by the FDA. The OBI-992 clinical trial is planned to target patients with advanced solid tumors, including non-small cell lung cancer, small cell lung cancer, gastric cancer, and several other cancers.
Ye Xinliang believes that the company's assets are still in an early stage, and cooperation with overseas biotech has certain advantages in the speed and priority of project advancement. "Licensing to MNC does have a bigger payoff, but it doesn't necessarily lead to a consensus on the development plan. Of course, as the assets move forward, we ultimately want to work with MNC at a more opportune time. ”
As Chief Strategy Officer and Head of Business Development for Biosion's China region, Yip is also responsible for corporate finance and IPO initiatives, as well as BD business in China. Based on Biosion's strategic positioning of "In Global For Global", Ye Xinliang and his team are actively exploring how to effectively integrate the strategic resources of global development and global capital to help Biosion's innovative assets in the process of global industrial development.
"We believe this is the next potential trend to lead the industry after license-out. "Through the hub-and-spoke model, the company forms a new subsidiary around a specific blockbuster asset. Relying on the competitiveness of assets and an international team to achieve overseas financing, listing or mergers and acquisitions, so as to accelerate the process of innovative drugs benefiting patients around the world. In fact, a similar operating model is quite mature in the European and American markets. ”
Roivant is a very successful example of this model. Since its inception in 2014, Roivant has spun off and combined more than 20 subsidiaries across multiple therapeutic areas. Axovant and Myovant, which were spun off from their parent companies, set records for the largest biopharmaceutical IPOs in the U.S. market in 2015 and 2016, respectively.
Ye Xinliang believes that at present, China's capital market has entered a period of contraction, and financing and IPO have encountered relatively large difficulties, on the contrary, the license-in and investment and financing in the US market still maintain good vitality, and there have been many large-scale transactions around Chinese assets recently. Chinese pharmaceutical companies can try to continue to advance important pipelines in overseas markets through asset restructuring models, and look for opportunities to cooperate with MNC or mergers and acquisitions.
"Biosion's exploration of this model is based on the company's proprietary technology platform, which enables the sustainable and stable development of internationally competitive innovative drug candidates. We have a very rich pipeline, but it's hard to fully realize their value in a company. The hub-and-spoke model allows us to streamline, efficiently and purposefully operate internationally. At the same time, we have a complete international team that can support the company in making such attempts. Ye Xinliang said.
Opportunities for platform companies
It has been seven years since the company was founded in 2017 to 2024, when Leading Asset obtained overseas clinical phase 2 PoC data. After ten years of sharpening the growth rate of a sword, Biosion did not catch the train of rapid development of the industry in the first place. It is conceivable that when the industry is in a high-speed development cycle and capital pursues rapid exit, there are not many opportunities for platform companies.
When capital enters a period of contraction, over-reliance on license-in will fall into a transformation bottleneck. Capital has re-examined the value of new drug R&D companies with technology platforms, and Biosion, which has been in the technology field for many years, has also begun to emerge.
"Our innovations come from within, we don't need to spend money to buy assets, and we have the ability to continue to go global. These advantages are even more prominent in the capital winter. Ye Xinliang said, "Not everyone in the industry can catch up, but the development of innovative drugs is not achieved overnight, which requires us to continue to accumulate our own technology and make real innovative drugs guided by the needs of patients." Although it is hard to find thousands of waters, blowing all the sand to gold, as long as we precipitate the powerful power of source innovation, we will also stand out in the industry. ”
At the end of 2022, Biosion completed nearly 200 million yuan in Series B/B+ financing. Ye Xinliang said that the company is actively strengthening its strategic positioning, developing global development partners, integrating international capital resources, and looking forward to further improving the company's operating model and efficiency in the near future.
Edit | Yao Jia [email protected]
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