ZhiKang Hongyi: Building Momentum with an End-in-Mind Strategy

As 2023 draws to a close, a look back at the year reveals that while overall investment and financing activity in the biopharmaceutical sector has remained sluggish, certain niche segments appear to be leading the way in recovery.

The ADC sector is undoubtedly the star of this year. A series of blockbuster deals related to ADCs, along with one Chinese innovation after another taking center stage on the global platform, have not only invigorated the international business development (BD) market but also drawn significant attention from investors in both primary and secondary biopharmaceutical markets toward the ADC sector.

In contrast to the gradual heating up of the ADC sector, the field of chronic kidney disease (CKD) appears to have “suddenly” garnered unprecedented attention. With Novartis acquiring Chinook Therapeutics, a nephrology-focused company, for $3.5 billion, and leading players in diabetes—headed by Novo Nordisk—announcing positive results from large-scale clinical trials in diabetic kidney disease, CKD is emerging as the next hotspot for R&D and investment.

With the emergence of these trends,Some low-profile biotech companies in China are beginning to attract market attention, and Wuxi Zhikang Hongyi Biotechnology Co., Ltd. is one of them.With less than six years since its establishment, the company already has seven products in clinical development, most of which are at a global leading stage. In the field of ADCs, Zhikang Hongyi has developed the world’s exclusive CDH3 ADC and is advancing it rapidly through clinical trials, drawing significant industry attention. It is reported that a series of ADCs targeting innovative antigens are also in rapid preclinical development. In the area of chronic kidney disease, the company has long positioned a potential best-in-class small-molecule ETA antagonist, which is currently in Phase II clinical trials.

This has sparked widespread curiosity: Why has the company built such an extensive pipeline? What is the underlying logic behind its selection of products and indications? Recently, we had the exclusive opportunity to interview the executive team of Zhikang Hongyi, revealing that this consistently low-profile company possesses a solid foundation and remarkable resilience. It has made steady and substantial progress in team building, pipeline selection, clinical development, and international cooperation.

“China does not lack pharmaceutical companies, but it urgently needs more high-quality innovative enterprises and innovative products that address critical unmet clinical needs."The innovative drug business requires both professionalism and focus. We are committed to turning scientists' ideals into reality and translating patient needs into products." Speaking about the original intention behind founding Zhikang Hongyi, Jia Xiangbo, who has over a decade of entrepreneurial experience in the pharmaceutical industry, said.

As early as 2003, Jia Xiangbo entered the pharmaceutical industry by acquiring and restructuring a Sino-foreign joint venture pharmaceutical company in Wuxi. Since then, he has been involved in every aspect of the business, from facility construction, R&D and regulatory registration, production, sales, and medical insurance procurement, to policy research, strategic management, team building, and business development, witnessing tremendous changes in regulatory policies and the industrial landscape. “I have also worked across different industries, but developing drugs has always been my greatest passion. Beyond sentiment, however, success requires capability, timing, and favorable conditions. Benefiting from the explosion of new drug targets, the return of overseas talent, and favorable policy dividends, I felt around 2016 that the opportunity to transition into innovative drug R&D was becoming increasingly mature and urgent,” recalled Jia Xiangbo. In 2016, he transferred his Wuxi manufacturing plant to WuXi AppTec, leading to the establishment of WuXi STA. “Collaborating with WuXi AppTec’s founding members and management team deepened my connection with the WuXi community and gave me a unique perspective and understanding of the CRO business model and its value.”

“I aim to build a leading Chinese biopharmaceutical company with a pipeline of continuously innovative products and robust commercialization capabilities.” Introduced by a senior scientist in the industry, Jia Xiangbo met Dr. Wang Yiwei in 2016, who was then engaged in translational medicine research in the Department of Clinical Pathology at the Cleveland Clinic in the United States. Dr. Wang is a scientist with a solid interdisciplinary background and profound expertise in disease biology.

“The experience I gained in translational medicine research at the Cleveland Clinic helped the company save a significant amount of time in target screening and validation, particularly as I have a thorough understanding of the mechanisms underlying most oncology targets.”At that time, after obtaining his bachelor’s degree in basic medical sciences and his Ph.D. in genetics, Wang Yiwei had already worked at the Cleveland Clinic for many years. He had undertaken the challenge of building a laboratory of more than fifty people from scratch and had led teams in extensive cutting-edge work, including tumor target validation, biomarker development, animal model establishment, and pharmacological and efficacy testing. “From a personal perspective,”I prefer to avoid engaging in so-called ‘involutionary’ pursuits, and instead focus on developing next-generation targets with a higher likelihood of successful drug development, thereby meeting clinical needs through differentiated solutions.“After extensive and thorough communication over a long period, Mr. Jia and I reached a consensus on these ideas. Therefore, I chose to return to China and assisted Mr. Jia in founding Zhikang Hongyi at the end of 2017,” said Wang Yiwei.

“At the end of 2017, I invested in myself and embarked on another entrepreneurial venture in my life,” Jia Xiangbo told reporters.

In 2021, after more than three years of effort, Zhikang Hongyi has obtained clinical trial approvals for multiple drug candidates. The company has achieved its first-phase strategic goal—initially establishing a product pipeline with Best-in-Class (BIC) potential. Building systematically leading clinical development capabilities has become the new strategic priority. Regarding Dr. Hei Yongjiang, the Company’s Co-CEO (and CMO), Jia Xiangbo stated: “He is a highly senior clinical medical scientist who has served various multinational pharmaceutical giants and small biotechnology companies. With leadership experience in both international and domestic clinical trials, he possesses extensive clinical development expertise across diverse technological modalities, including small molecules, large molecules, and antibody-drug conjugates (ADCs). His profile aligns exceptionally well with the company’s pipeline and stage of development, and his joining has rapidly elevated the company’s clinical development capabilities to international standards.”

When discussing Dr. Eric Rowinsky, the company’s U.S. Chief Medical Officer (CMO), Jia Xiangbo noted that Eric had already been serving as a clinical research advisor to the company before joining ZhiKang Hongyi. This year, he officially joined Wuxi Zhikang Hongyi Biotechnology Co., Ltd. as U.S. CMO, overseeing U.S. clinical trials under the leadership of He Bo. “Eric boasts an impressive resume. He previously served as an Associate Professor of Oncology at Johns Hopkins University, facilitated the U.S. market launch of multiple blockbuster novel drugs such as cetuximab and ramucirumab, has served on the boards of directors of several well-known publicly listed companies, and has independent experience in managing clinical operations in North America. Eric has participated in discussions on nearly all of the company’s clinical protocols, helping secure U.S. clinical trial approvals for four projects. The collaboration of top-tier experts creates a synergistic effect where 1+1>2; the dual-CMO mechanism better ensures the accuracy and scientific rigor of clinical development.”

Jia Xiangbo places great emphasis on out-licensing, describing it as the most efficient path for the company to maximize the value of its innovations. As clinical trials progress, advancing international rights collaborations will be a key objective for the company’s next phase. “We have identified a highly suitable BD Leader. After in-depth discussions spanning six months, Dr. Kaan Certel, formerly Head of Global Oncology Out-Licensing at Sanofi, officially assumed the role of Chief Business Officer (CBO) one month ago. Since joining, Dr. Kaan has leveraged his extensive global business development experience and resources to drive significant progress, building upon the company’s existing foundation,” Jia Xiangbo stated regarding the new CBO.

After six years of development, Zhikang Hongyi has assembled an international team with extensive experience and a proven track record of success across all stages of novel drug discovery and development. Reflecting on the team-building process and its consistent principles for identifying and employing talent, Jia Xiangbo stated, “There are three most critical factors: First, there must be thorough prior communication between both parties to clearly understand each other’s capabilities and limitations, fostering chemical synergy and trust through interaction. Second, everyone must share clear common goals and align with the company’s mission, vision, and values, rather than maintaining collaboration solely based on financial interests. Third, it is essential to define responsibilities and work boundaries that are understood and accepted by all.”

Zhikang Hongyi has a distinct characteristic: it is grounded in disease biology and clinical medicine, placing high importance on the pivotal role of translational medicine across all stages, including project initiation, molecular design, and clinical development.

Wang Yiwei stated, “The pathogenesis of both tumors and chronic kidney disease is highly complex, with long-standing unmet clinical needs,”Synergy of Multi-Target and Multi-Technological Approaches Better Meets Clinical Treatment Needs for Diseases, the continuous discovery of new targets and the iteration of diverse technological approaches have created opportunities for current drug innovation. In the field of oncology, we have mapped out multiple landscapes covering targets, diseases, and drug development, proposing a strategic shift from anti-tumor therapy to the treatment of anti-tumor drug resistance. Based on distinct mechanistic characteristics and the needs associated with different disease stages, we have prioritized the identification of differentiatedThree Major Directions: Tumor Immunology, Synthetic Lethality (DDR), and Antibody-Drug Conjugates (ADC). In the field of nephrology, priority was given to those with multiple potential indicationsNew-Generation Endothelin Receptor Antagonistsfor development.”

“Targets are public yet scarce resources; the company’s primary objective is to develop highly promising new targets and maximize the value of each one.”Wang Yiwei stated, “Zhikang Hongyi meets clinical needs by strengthening basic research in disease biology and leveraging translational medicine to discover and identify new targets. Meanwhile, it fully exploits the mechanisms of action of these targets through more suitable technological platforms, thereby increasing the success rate of target development. This approach has ultimately resulted in the company’s current product pipeline, which spans multiple modalities.”

“Project initiation marks the starting point of commercialization; we consistently focus on next-generation high-profile targets.”Apart from FIC products, the company’s projects must achieve a development ranking within the top three in China and the top five globally upon entering clinical trials.“She further explained the reasons why each pipeline holds a leading advantage. Furthermore, ‘a clear scientific mechanism, long-term clinical needs, long-term commercial value, and trends in regulatory policy changes are all factors we consider when initiating projects.’”

Wang Yiwei noted that translational medicine plays a significant role in drug discovery and preclinical development. Taking the development of the company’s CDH3 ADC product as an example, extensive translational medicine research was conducted in the early stages. This included innovative target development and screening of toxins specifically for lung cancer indications, thereby maximizing the likelihood of clinical success.

Regarding the company’s pipeline strategy, Hei Yongjiang added, “From a clinical perspective, our oncology pipeline portfolio offers inherent potential for combination therapies, which helps reduce clinical development costs. We can also conduct collaborative clinical trials with other companies. This diversified approach expands clinical application scenarios and future commercialization opportunities, leveraging a ‘one for more’ effect. As for whether and how combinations should be implemented, our translational medicine team will conduct thorough validation.”

Jia Xiangbo also shared his insights from the perspectives of corporate operational risk and commercialization: “New drug development is a high-risk, long-cycle endeavor. For companies with only a single pipeline or very few pipelines, the failure of a single product can easily have a significant impact. From a commercialization standpoint, especially in the Chinese market, a single product targeting a small indication is often insufficient to support large-scale commercialization. A rational product portfolio is essential to help companies better achieve their commercial objectives.”

As an innovative technology company with seven clinical-stage products that are first-in-class (FIC) or potential best-in-class (BIC), what development strategies and principles of Wuxi Zhikang Hongyi Biotechnology Co., Ltd. are worth anticipating?

“We must always adhere to the principle of ‘beginning with the end in mind,’ gain insights into current and long-term unmet clinical needs, and conduct thorough population analysis and indication positioning.” Hei Yongjiang emphasized, “We should allocate the best resources to the most promising projects. Although every product from Zhikang Hongyi has the potential to become a blockbuster,Projects with clear druggability, a high likelihood of conditional approval for monotherapy, and a high degree of certainty in international rights collaboration will be prioritized for company support., but this is a dynamic process, with data being the most critical determinant.”

Hei Yongjiang stated, “Exploring combination therapies represents another approach. Overall, combination drug therapy based on different mechanisms of action is a clear trend.” This September, Wuxi Zhikang Hongyi Biotechnology Co., Ltd. signed a collaboration agreement with AstraZeneca for its PD-L1 monoclonal antibody and an anti-TIM-3 monoclonal antibody to jointly conduct Phase Ib/II clinical studies in China for the treatment of hepatocellular carcinoma (HCC).

Zhikang Hongyi has already obtained clinical trial approvals for multiple products in both China and the United States. Hei Yongjiang stated that, under the current circumstances, the company’s strategy isPrioritize dose-escalation studies in China, and upon obtaining favorable data, concurrently conduct population expansion trials in both China and the United States, based on the product’s internationalization potential., to enhance the efficiency of clinical development and capital utilization.

According to Hei Yongjiang, the company’s product development is being rolled out in a tiered manner. In addition to the high-ETA-selectivity candidate, which will enter Phase III clinical trials in 2024, the remaining products will primarily undergo Phase Ib and Phase II trials. This strategic layout helps balance the company’s resources. Furthermore, the company’s rigorous budget management, cost control, and operational efficiency contribute to effective cost containment and maximized resource utilization.

“In 2024, most of the company’s products are expected to reach significant milestones and achieve proof-of-concept (POC), which will benefit our business development efforts and, we believe, also facilitate fundraising,” said Hei Yongjiang.

In terms of international business development (BD) collaborations, multiple products from Zhikang Hongyi are currently in discussions with multinational corporations (MNCs).Among them, the most sought-after assets are the company’s globally exclusive CDH3 ADC and ETA small-molecule antagonist.

Dr. Kaan Certel, Chief Business Officer, explained his reasons for joining Zhikang Hongyi: “Prior to joining, I engaged in in-depth discussions with the company’s team and conducted a thorough analysis of its product portfolio. Nearly every one of the company’s products is at a global leading stage of development, demonstrates strong drugability potential, and has yielded encouraging clinical data to date. Like all my U.S. colleagues, I am highly confident in the company’s future. As a biotech firm, Zhikang Hongyi impresses with its profound understanding of commercialization, respect for science, and mutual trust among team members.”

“I am confident in my ability to contribute value to the company’s development.The BD team and I have developed a plan, aiming to achieve significant breakthroughs in business development over the next six months.“The company’s consensus is to maximize product value, prioritize collaborations with multinational corporations (MNCs), and create value for more patients worldwide,” Kaan added.

Postscript:Amid the “winter,” we are witnessing a steady rise in the innovation capabilities of Chinese enterprises, with their global expansion accelerating and taking on increasingly diverse forms. We are also seeing Chinese products continuously gain market approval from the FDA and EMA, earning international recognition. A more robust Chinese innovative drug industry is emerging. Let us join forces to embrace the coming spring.