Riding the tide, realize the future: The BD paths for Chinese Biotech

WUXI, ChinaNov. 14, 2023 /PRNewswire/ -- 2023 BIO-Europe just closed last week. In line with previous conferences, this BD carnival attracted more than 2,000 companies, 5,000 attendees from close to 60 countries all over the world.

Recently, we interviewed a global BD expert, Dr. Kaan Certel.  He was formerly the Global Head of Oncology External Innovation, Sanofi Partnering. Now he serves as Chief Business Officer of Biocity Pharmaceutics, a Chinese biotech. Form both angles, he shared his views on Chinese biotech transformation and the key points and prospects of BD collaboration between Chinese biotech and MNCs.

Q: Congratulations on your new position! Firstly, why did you choose to join BioCity? What are the highlights of this company?

A: BioCity is a young, significantly differentiated innovative Chinese biotech with a competitive portfolio in oncology and chronic kidney disease including 7 exciting assets in clinical development phase. The company was founded by Mr. Xiang Bo Jia and Dr. Ivy Wang in 2017. Subsequently, the cofounders recruited Dr. Yong Jiang Hei as the Co-CEO and CMO. The leadership built the company on solid foundation: A patient-centric approach that aims to develop innovative drugs with urgency, born out of a deep understanding of the disease biology and target space. Importantly, each decision point of the development process is data driven. While patient care is front and center, this strategy also creates programs with robust commercial value across all geographies. The approach and the philosophy of the company is an excellent example of the transformation that is exciting the multinationals, who are seeking novel pathways and biology to target, particularly in oncology. In my assessment of thousands of companies during my previous role in Sanofi as the Global Head of Oncology External Innovation, I have rarely come across biotech that brought together all these qualities in China or elsewhere. Therefore, it was not a difficult decision to join this progressive company.

Q: Thank you. According to your experience and observation, how's the biotech scene changing in China?

A: Over the last few years, China has taken the global lead in scientific innovation. A report published by Japan's National Institute of Science and Technology Policy (NISTP) and printed by the Guardian found that China now publishes the highest number of papers annually, followed by the US and Germany. According to the article, China not only overtook the US in terms of the number of papers published but also in terms of the high impact studies. We're now beginning to see the translation of this progress into innovative pipelines, transforming the face of biotech in China. While emulating the success of proven assets with a fast-follower, me-too approach still prevalent, a few companies are taking the lead by building exciting pipelines with First-in-Class assets targeting novel pathways and biology. The clear recognition of the success of this approach is evident by the recent partnerships between multiple multinational pharma and relatively small Chinese biotech companies. The relatively rich deal terms reflect the potential impact of these programs on improving patients' lives. Oncology still dominates the innovation space, but a few companies are expanding this horizon into additional therapeutic space, such as immune/inflammation, metabolic disorder, and kidney disease.

Q: Let's get back to BD. What strategies should a biotech company follow to create a competitive pipeline?

A: The company pipeline must strategically combine three concepts: addressing unmet need, performing high quality science, and creating commercial opportunity. This philosophy is essential to create value for patients and shareholders. The pathways and biology explored must be well-validated in the context of the disease. Companies should be open-minded about the modality, the mode-of-action of addressing a target should be scientifically driven. Innovation does not reward copycats, nor should it be taken at face value. Nowadays it becomes more and more difficult to draw a fine line between small molecule companies andbiologics companies. Of course, platform companies will continue to emerge, but they will continue to face significant challenges on the investment side since it's very difficult to assign value to a platform.

One productive model is to build a pipeline consisting of pillars that can create synergies through potential combination therapy strategies to address multiple indication spaces, maximizing the opportunity space and asset reach by those in need.  The growth of the company will be catalyzed by building around these pillars to solidify the position of the company. BioCity has accomplished this by building a portfolio that focuses on three pillars in oncology: DNA Damage Response (DDR) pathway, Immunooncology, and Antibody-drug conjugates (ADCs). As a result, BioCity is well-positioned to address both the FIC and the BIC spaces with multiple modalities including small molecules, multi-specific antibodies, and antibody-drug conjugates (ADCs) across multiple therapeutic areas.

Q: How should biotech companies think about the risks associated with innovation?

A: An important component for the continued success of Chinese biotech transformation is the strategic focus. Creating a portfolio of innovative products require novel approaches and calculated risk taking. A great example of this is the current dominant position of Chinese biotech companies in ADC space. Novel targets, novel conjugation methods, and novel cytotoxic payloads differentiate the assets and grab the attention of large pharma companies that are on the hunt for novel assets. The approach should be a strategic one. The value of yet another KRasG12C, or PD-1 inhibitor is not compelling for the investors or the patients. The strategy should begin with understanding the current need and the landscape for each indication and finding the right path to innovation. It is critical to understand the Return on Investment (ROI) for each portfolio asset. The leadership must carefully analyze the investment necessary to develop each program to a point of partnership and put that in the context of expected return from that asset, including the patient population that could potentially benefit from it. Of course, the goal is not to create a pipeline solely focused on a large ROI. The company strategy should favor a balanced portfolio driven by both science and business.

Q: What are MNCs prioritizing for potential collaborations, and what are the key points to be taken for Chinese biotech?

A: Large pharma companies look for First-in-Class (FIC)/Best-in-Class (BIC) assets with significant commercial potential across the globe. Currently, multiple large pharma companies face significant portfolio challenges in the form of patent cliffs and clinical trial failures. The industry overall is under significant stress and the investor confidence is low.  Multinationals are continually reassessing their strategic priorities while focusing their pipelines. Loss of exclusivity and late-stage clinical trial failures pressure the large pharma companies to leverage partnerships, especially on clinical-stage programs, to bridge the revenue gap they are facing. In this current climate, there's significant incentive to focus on and expedite the development of promising programs with compelling data. In order to reduce risk, large pharma companies are prioritizing programs with efficacy signal and good safety profile.  Although multinational companies rely heavily on scientific and commercial diligence in their collaboration decisions, they understand that when they enter into a partnership, they are also investing into team expertise in addition to the asset. Therefore, the quality of the teams is just as important as the assets. In this regard, once again, BioCity presents a great example. At BioCity, high-quality pipeline assets are developed by an experienced and dedicated team both in China and the US.

Q: What are some important considerations in structuring a deal that you could share?

A: First and foremost, it is crucial to select the right partner to enter into complex, at times difficult negotiation process. The partner should be willing to listen to BioCity concerns and address them in mutually beneficial ways. The process moves much more efficiently with a partner that share the same fundamental philosophies.

The economic terms of the deal are, of course, important, particularly for the small biotech whose investment represents a significant risk. The upfront and milestone amounts should reward the success of the programs in recognition of that fact.

Partners will also have to align on sharing the rights to the programs across various geographies. Promotion and commercialization terms in this regard are very important as strength in this area will determine the reach of the drug and drive sales. For example, BioCity will prioritize retaining the rights in China for development and commercialization while utilizing partner capabilities in the rest of the world as it would not be practical to invest into a global commercialization force for BioCity at this phase of the company.

Similarly, rights governing further clinical and preclinical research on the targets must be balanced to allow both parties to expand the benefits of the program. In doing so, however, small biotech companies need to be cognizant of the resource limitations as overstretching the goals could create significant financial stress on the company.

Finally, in my view, one of the most critical parts of the contract is the termination clause. While we always plan for success, we should also be prepared for the failure of the programs at various stages and plot exactly how we will manage potential outcomes before we face them.

Q: Thank you. Our second-to-last question: what is BioCity's partnering strategy?

A: A successful partnering strategy should focus on maximizing the value of the programs and providing global access to patients across geographies expeditiously. Most large oncology indications remain as high unmet need spaces with dismal 5-year survival expectancy. Therefore, BioCity BD team will focus on partners that will help speed up progress in clinic across broad indication spaces. Our aim is to create deal structures that will set up a win-win-win scenario for both partners as well as the patients. As we develop into a global company born in China, we also recognize the importance of retaining significant value of our programs in China through creative deal structuring. This will pave the path for strengthening our clinical development capabilities and building a commercial force in China. For ex-China territories, we will focus on leveraging partner's global capabilities in clinical development and commercialization. The goal of our BD activities at BioCity is to create value for our shareholders and the patients.

Q: Last question. How will the BioCity BD team work together to execute on this strategy?

We have now begun to reach out to MNCs to socialize our clinical stage programs to explore potential partnership paths. As we meet with our potential partners, we are learning about what additional data that might be necessary to move into deeper licensing discussions. Based on this information we are in the process of assessing each program under multiple partnership scenarios to position the entire portfolio in the strongest possible shape. We have initiated good dialogue with multiple potential partners, and we will continue to cultivate these relationships as we advance the programs to their appropriate inflection points. We believe the inflections would happen not far in the future.

Based on the portfolio with great potential, BioCity has built a young, energetic, and competent BD team. As the leader of this team, I am excited to work side by side with my team members and help guide their professional development process. I have all the confidence that the team will blossom into a strong group of BD professionals in a relatively short period of time. The team's development will play an important role in the short-term partnering activities as well as the long-term growth phase of the company.

About Dr. Kaan Certel

Dr. Kaan Certel has over 20 years of academic and industry experience. He is a globally recognized business development expert, also he is a cancer biologist with a deep understanding of genetics, cell biology, and immunology.

Recently, Kaan has been appointed as the Chief Business Officer of Biocity Biopharmaceutics. In this role, he is responsible of leading the company's global BD activities, and supporting strategic management affairs. Before joining BioCity, he was the Global Head of Oncology External Innovation, Sanofi Partnering, where he led a team of senior level professionals to identify and assess potential in-licensing and collaboration opportunities.

His previous R&D experience includes small molecule discovery at X-Chem Pharmaceuticals and antibody discovery at X-Body Biosciences, which is now a part of Bristol Myer Squibb. His expertise expands multiple therapeutic areas such as oncology, immune-oncology, and autoimmune diseases.

Kaan received his Ph.D. degree in Genetics from the University of Iowa and had his postdoctoral training in the Koch Institute for Integrative Cancer Research at MIT.

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