--- title: "Exclusive Interview with Shen Yulei of Bioits: \"Unveiling\" a BD Deal Completed in Just Four Months" type: "Topics" locale: "en" url: "https://longbridge.com/en/topics/42849156.md" description: "From the official launch of cooperation to the signing of the agreement, it took only about four months. Looking back at the BD cooperation between Bio-Thera Solutions and Nasdaq-listed Whitehawk Therapeutics, the entire project advancement speed was far faster than similar projects in the industry. "What truly facilitated the cooperation, besides the encounter at the AACR (American Association for Cancer Research) annual meeting, was more importantly the trust established between both parties based on long-term attention, sufficient communication, and high demand alignment." "During the advancement process, there was almost no obstruction in communication between the two parties..." datetime: "2026-07-22T08:33:11.000Z" locales: - [en](https://longbridge.com/en/topics/42849156.md) - [zh-CN](https://longbridge.com/zh-CN/topics/42849156.md) - [zh-HK](https://longbridge.com/zh-HK/topics/42849156.md) author: "[若波投研](https://longbridge.com/en/profiles/26711817.md)" --- # Exclusive Interview with Shen Yulei of Bioits: "Unveiling" a BD Deal Completed in Just Four Months From the official launch of the cooperation to the completion of the agreement signing, it took only about four months. Looking back at the BD cooperation between Bio-Thera Solutions and Nasdaq-listed Whitehawk Therapeutics, the entire project advancement speed was far faster than similar projects in the industry. "What truly facilitated the cooperation, besides the encounter at the AACR (American Association for Cancer Research) annual conference, was more importantly the trust established between the two parties based on long-term attention, sufficient communication, and high alignment in needs." **"During the advancement process, there were almost no obstacles in communication between the two parties. Whitehawk's technical team and legal department responded extremely quickly, and Bio-Thera Solutions internally maintained the same pace, with no reversals in between. Everyone just wanted to get things done quickly.**" Dr. Shen Yulei, Chairman and CEO of Bio-Thera Solutions, evaluated this when interviewed by Arterial Network. ![Image](https://pub.pbkrs.com/uploads/2026/9cb8cd06e7c80f9e459744d6baf1e000?x-oss-process=style/lg) _Dr. Shen Yulei, Chairman and CEO of Bio-Thera Solutions_ It is understood that recently Bio-Thera Solutions and Whitehawk Therapeutics, Inc. announced that both parties have signed a global strategic cooperation agreement covering multiple bispecific antibody-drug conjugate (BsADC) R&D projects. The two parties will jointly promote a diversified pipeline of next-generation therapeutic products. The efficient advancement of this cooperation was not accidental. Behind it lies the precise matching of both parties' needs. Moreover, this cooperation not only signifies the formal landing of a BD project but also reflects changes occurring in the overseas expansion of Chinese innovative drugs: **more and more overseas enterprises are no longer just focusing on a single mature candidate molecule, but on R&D platforms capable of continuously producing high-quality molecules.** **01.** **A BD Cooperation Reached in Four Months** Dr. Shen Yulei told Arterial Network that actually, at the beginning of 2026, Whitehawk had already paid attention to Bio-Thera Solutions and its related bispecific ADC research achievements, having an initial understanding of Bio-Thera Solutions' platform capabilities. **As exchanges deepened, in March 2026, Whitehawk and Bio-Thera Solutions formally signed a CDA (Confidential Disclosure Agreement), initiating technical and business discussions around bispecific antibody cooperation.** It is understood that during the evaluation stage of BD and other project cooperations, both parties need to exchange a lot of sensitive information, such as molecular structures, platform technology details, experimental data, etc. The CDA ensures that this information will not be leaked or used for purposes beyond those agreed upon in the protocol. Before cooperation, signing a CDA can be seen as a prerequisite for launching substantive technical and business discussions, allowing both parties to assess cooperation potential in a safe environment. Therefore, it is often regarded as the first step before formal cooperation. By April 2026, in San Diego, USA, the AACR annual conference venue was bustling with people. In front of Bio-Thera Solutions' booth, posters displaying data on bispecific ADCs (antibody-drug conjugates) attracted the attention of passing researchers, **which also became an important opportunity for the first in-depth offline exchange between Bio-Thera Solutions and Whitehawk.** During the AACR annual conference, the two parties conducted systematic discussions around Bio-Thera Solutions' RenLite® common light chain platform, bispecific antibody development strategies, and future cooperation models, further accelerating the promotion of cooperation. "Actually, this cooperation came at just the right time. At that time, Whitehawk was actively looking for a platform capable of continuously producing high-quality bispecific antibodies, while our RenLite® common light chain platform and several cooperation projects that have obtained clinical validation provided them with full confidence. Both parties were highly aligned in cooperation philosophy, R&D thinking, and project advancement methods, so the entire cooperation process was very smooth." Dr. Shen Yulei stated. **After continuous technical evaluation, business discussions, and agreement negotiations over several months, both parties finally completed the signing of the cooperation agreement on June 30, 2026.** According to official website information, in March 2025, Whitehawk completed a strategic restructuring, subsequently focusing on the R&D of next-generation ADC drugs. Currently, Whitehawk has three ADC pipelines (HWK-007, HWK-016, HWK-206), the first two of which have entered Phase I clinical trials. As of March 31, 2026, Whitehawk held cash and equivalents of approximately $123 million, expected to support operations until 2028. **It is understood that all three of Whitehawk's pipelines were licensed from WuXi Biologics.** In December 2024, WuXi Biologics announced an agreement with Aadi Bioscience (the predecessor of Whitehawk) and others to empower Aadi Company to develop three new-generation ADC drugs in the preclinical stage, with a upfront payment of $44 million and a total agreement value of up to $849 million. In the agreement reached with Bio-Thera Solutions this time, Bio-Thera Solutions will provide up to five fully human bispecific antibodies through the RenLite® platform. Whitehawk will evaluate them in combination with its ADC linker-payload platform technology and may choose to include the resulting BsADC candidate molecules in its pipeline for development advancement. Regarding the number "five," Dr. Shen Yulei revealed to Arterial Network: **"This is only the scale of the first phase of cooperation. We start with 5. If the cooperation goes smoothly, more may be added later."** **Different from Bio-Thera Solutions' past cooperation model mainly focused on PCC molecule License outs, this cooperation leans more towards platform-driven early joint development.** What Whitehawk values is not a specific ready-made candidate molecule, but Bio-Thera Solutions' ability to continuously produce high-quality bispecific antibodies, as well as the reliability of the RenLite® platform verified through multiple cooperation projects. **02.** **Why Bispecific ADCs Are Favored** This cooperation focuses on bispecific ADCs. If you review global ADC pipeline data, a set of numbers is quite shocking: **According to statistics by Beacon at the end of 2025, there are already over 3,800 global ADC candidate drugs.** Behind the surge in numbers is the high repetition of targets. Hot targets such as HER2, TROP2, and B7-H3 have gathered a large number of products in development. Moreover, under the heat wave, among thousands of ADC molecules in development globally, only 1% have successfully been commercialized so far. Because ADC drugs are quite complex, they need to ensure both efficacy and safety simultaneously. Target selection, antibody performance, linker stability, payload toxicity... every detail is a matter of life and death. **More and more R&D teams realize that besides changing the Payload or optimizing the Linker, the antibody itself is also a key factor determining the upper limit of ADC drugs.** This trend is particularly obvious in the field of bispecific ADCs. Dual targets can recognize two antigens simultaneously, improving endocytosis efficiency and effectively preventing drug resistance caused by the loss of a single target. In the world's most cutting-edge bispecific ADC field, the proportion of Chinese projects soared to 59% in 2025. In Dr. Shen Yulei's view, behind the heating up of bispecific ADCs is the industry's pursuit of durable efficacy. Single-target therapy often encounters problems such as target disappearance or activation of compensatory pathways, while dual-target design can achieve more comprehensive blockade from multiple levels such as compensatory signaling pathways. **Dr. Shen Yulei believes that the long-term potential of bispecific ADCs may be higher than that of monoclonal ADCs, precisely because of the durability of efficacy. Even if monoclonal ADCs can see tumor shrinkage, the extension of PFS (Progression-Free Survival) and OS (Overall Survival) is often limited, whereas bispecific ADCs are expected to bring qualitative changes.** However, compared to traditional monoclonal antibodies, antibody engineering is one of the biggest challenges in bispecific development. Problems such as heavy and light chain mismatch, molecular stability, and developability have long constrained R&D efficiency. Therefore, technology platforms that can reduce molecular engineering complexity from the source during the antibody discovery stage, and improve natural pairing rates and developability, are receiving increasing attention. This is exactly the core value of Bio-Thera Solutions' RenLite® common light chain platform. According to Dr. Shen Yulei, this platform adopts a fixed light chain design—the light chain is fixed, and the light chains produced by all antibodies are the same. When making bispecific antibodies, one only needs to focus on the heavy chains, eliminating the problem of heavy-light chain mismatch. "By creating a knob-into-hole structure between the heavy chains, a very complete and stable common light chain bispecific antibody can be made." In fact, Bio-Thera Solutions began laying out bispecific ADCs as early as 2021. At that time, the industry did not pay much attention to this direction, but the Bio-Thera Solutions team found in preclinical studies that **bispecific ADCs showed significantly better efficacy and safety on PDX models compared to their corresponding parent monoclonal ADCs.** "When communicating with the industry at that time, many people did not favor bispecific ADCs. We even doubted whether we had taken the wrong direction. Subsequently, we decided to push forward to clinical trials together with partners. Persisting until now, bispecific ADCs have become an industry-recognized development trend." Dr. Shen Yulei told Arterial Network. **For bispecific ADCs, the difficulty in making a good antibody lies in screening.** Dr. Shen Yulei explained this logic with a vivid metaphor: It is like looking for the sturdiest saplings in a nursery. If you only plant 50 trees, you might not find a single one suitable for being a pillar; but if you plant 500,000 saplings, then the probability of finding thick, straight, and pest-resistant saplings increases greatly. **"Making antibodies is the same. There cannot be glycosylation, deamination, easily oxidizable sites, or easy aggregation. It also needs good hydrophilicity. For ADC drugs, high endocytosis efficiency is also required. To meet all these standards, a sufficiently large library is needed to screen for that 'best of the best' molecule."** This is also the core logic behind Bio-Thera Solutions' launch of the "Thousand Mice, Ten Thousand Antibodies" plan—using a scaled antibody library to increase the probability of finding good antibodies, thereby providing truly differentiated "weapons" for the industry in the second half of the ADC competition. **03.** **Seven Years to Grind One "Mouse"** The reason why Bio-Thera Solutions could launch the "Thousand Mice, Ten Thousand Antibodies" plan all starts from the "mouse". In 2013, Dr. Shen Yulei decided to do something difficult and long-term: develop fully human antibody mice. **This task was difficult because what needed to be modified was not just a few thousand base pairs of the mouse, but millions,** replacing the variable regions of the mouse's heavy chain gene and κ light chain gene responsible for producing antibodies with the corresponding human genes. At that time, only Regeneron and the UK's Kymab possessed fully human antibody mouse platforms. Regeneron spent nearly 20 years replacing mouse antibody genes segment by segment, ultimately constructing the fully human antibody mouse. **And what Dr. Shen Yuleai needed to do was not just to make the mouse, but more importantly, to explore a technological path with independent intellectual property rights.** "You cannot infringe on others' patents. To develop your own method, you must take a different path." One night at the end of 2019, past midnight, Dr. Shen Yulei and the fully human antibody mouse team were still in the laboratory, waiting for the results of mouse B-cell sequencing to verify whether their antibody sequences were truly human-derived. **"Those few hours of waiting were the most tense moments. The entire team had explored this for seven years. Since starting the project in 2013, this core team of seven or eight people had devoted their hearts and efforts, but no one knew when it would succeed."** Finally, the results came out. The antibody sequence was indeed human-derived. The young woman in charge of the project couldn't stop crying all day. Dr. Shen Yulei recalled: "Whenever she mentions this event, she tears up. That should have been tears of joy. The hardships behind it are really hard to put into words." This sentiment was not exaggerated. At that time, Bio-Thera Solutions chose a technological path completely different from Regeneron—chromosome engineering technology, attempting to replace millions of base pairs all at once. Regeneron adopted a segmented replacement method, taking nearly twenty years. Dr. Shen Yulei's team consisted of only seven or eight people. For several years in the early stages, they were developing this technology platform, and it was even uncertain whether they would ultimately succeed. It was precisely this long wait without knowing where the endpoint lay that made the verification result on that night appear especially precious. Subsequently, Bio-Thera Solutions built the RenMab® fully human antibody mouse platform. On this basis, Bio-Thera Solutions successively developed the RenLite® common light chain platform for bispecifics and bispecific ADCs, the RenNano® platform for nanobodies, etc., constructing the RenMice® fully human antibody platform family. In 2020, Bio-Thera Solutions' "Thousand Mice, Ten Thousand Antibodies" plan officially launched. Targeting over 1,000 potentially druggable targets, it conducted scaled antibody development on the RenMice series platforms, aiming to build a fully human antibody molecule library covering a wide range of targets. It is worth noting that the industry often attributes the competitiveness of "Thousand Mice, Ten Thousand Antibodies" solely to the antibody molecules themselves, which is not true. Dr. Shen Yulei explained to Arterial Network: **"The real competitive barrier of 'Thousand Mice, Ten Thousand Antibodies' lies in the target-humanized mice, which are the core tools for efficacy evaluation. Bio-Thera Solutions is already one of the largest suppliers of target-humanized mice globally. If pharmaceutical companies have already adopted our mice for drug evaluation, they naturally tend to obtain corresponding antibodies within the same system—just like buying a certain brand of mobile phone, the charger will naturally be chosen from the same brand."** The "Target-Humanized Mouse Library" is another core preclinical product of Bio-Thera Solutions. The aforementioned fully human antibody mice are mainly used for antibody R&D, **while target-humanized mice involve replacing specific drug target genes of mice with human genes, used for efficacy evaluation.** The establishment of the target-humanized mouse library was also not easy. In 2014, when Dr. Shen Yulei decided to build the target-humanized mouse library, opposition from the team was very intense. "At that time, the company's annual revenue was only tens of millions of yuan, but building animal housing required an investment of tens of millions, and monthly breeding costs amounted to millions. If no one bought our mice, the company might face a survival crisis." **"But I still decided to do it. Otherwise, we would only remain a small company that never grows big. When almost all enterprises engaged in antibody R&D in the industry cooperate with us and use our mouse models, Bio-Thera Solutions can truly possess influence."** Later stories proved that this decision was correct. Today, Bio-Thera Solutions' target-humanized mice exceed 2,000 types, covering most antibody drug enterprises. And "Thousand Mice, Ten Thousand Antibodies" is built upon this massive customer ecosystem—when Bio-Thera Solutions becomes the preferred supplier of target-humanized mice for global pharmaceutical companies for efficacy evaluation, providing antibodies becomes the most natural extension of demand. Today, "Thousand Mice, Ten Thousand Antibodies" has constructed a real fully human antibody molecule sequence library exceeding 1 million, and has advanced to version 2.0 empowered by AI and automation, covering various forms such as monoclonal antibodies, bispecific antibodies, and nanobodies, and is still expanding rapidly. **04.** **"Actually, We Didn't Do Any Transformation"** Looking back at Bio-Thera Solutions' 17-year development history, outsiders often describe it as transforming from gene editing services to model animal products, and then to fully human antibody platforms and "Thousand Mice, Ten Thousand Antibodies," but Dr. Shen Yulei does not think so. **"Actually, we didn't do any transformation. The original intention of founding the company was to develop antibody-humanized mice, and the realization of this goal relies on the support of gene editing technology; similarly, the R&D of antibody drugs inevitably requires target-humanized mice as evaluation tools. Therefore, from antibody-humanized mice to target-humanized mice, all work unfolds based on gene editing technology, following the same main line of technological logic."** Dr. Shen Yulei pointed out to Arterial Network. In Dr. Shen Yulei's view, Bio-Thera Solutions' positioning has never changed—to provide underlying tool support for drug R&D, to build the most underlying technology platforms, and to provide antibody molecules and evaluation models for global pharmaceutical companies. The ultimate vision of this positioning is to become **"the birthplace of global new drugs"**. Dr. Shen Yulei used a case to explain this vision: Merck's PD-1 antibody Keytruda originally came from the Dutch company Organon, which was later acquired by Schering-Plough, and Schering-Plough was subsequently acquired by Merck. Tracing back along the way, almost the entire industry knows where this molecule originated. **"Our vision is that in the future, the initial molecules of the vast majority of antibody drugs can be traced back to Bio-Thera Solutions. Perhaps one day, a drug passes through the hands of multiple companies, but when the industry traces its source, it will still discover that Bio-Thera Solutions was involved at its birth. This is the true meaning of the vision 'birthplace of global new drugs'."** As of the end of 2025, Bio-Thera Solutions had cumulatively signed over 350 drug cooperative development, licensing, or transfer agreements, establishing cooperation with many of the global TOP10 pharmaceutical companies. Overseas revenue accounts for more than 70%. Through these numbers, Bio-Thera Solutions may be getting closer to this vision. Reprinted from: Arterial New Medicine $Biocytogen(688796.SH) $BIOCYTOGEN-B(02315.HK) ![Image](https://pub.pbkrs.com/uploads/2026/c009be489569f5bbe5864cb10300e5c9?x-oss-process=style/lg) ### Related Stocks - [02269.HK](https://longbridge.com/en/quote/02269.HK.md) - [WXXWY.US](https://longbridge.com/en/quote/WXXWY.US.md) - [AADI.US](https://longbridge.com/en/quote/AADI.US.md) - [688796.CN](https://longbridge.com/en/quote/688796.CN.md) - [02315.HK](https://longbridge.com/en/quote/02315.HK.md) - [WHWK.US](https://longbridge.com/en/quote/WHWK.US.md)