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Antibody New Drug Developer

Dr. Wang Minghan, Founder and CEO of Phanes Therapeutics, Inc.
The year 2022, which has just passed, was a year of accumulation and breakthrough for Phanes Therapeutics, Inc. Under the close collaboration of two R&D centers in San Diego, USA, and Shanghai, China, three self-developed innovative drugs by Phanes Therapeutics were approved by the FDA to conduct Phase I clinical trials in the United States. Two of these original innovative drugs received FDA Orphan Drug Designation. For an innovative pharmaceutical company with more than 50 employees, this is undoubtedly an impressive report card that has drawn significant attention from peers.
According to the plan of Dr. Minghan Wang, founder of Phanes Therapeutics, Inc., the Phase I clinical trial of Phanes is expected to come to an end from the second half of 2023 to the end of the year. Based on these data, the company will apply for the Phase II clinical trials to be carried out simultaneously in China and the United States. If these innovative drugs are successfully marketed, they will provide new solutions for malignant tumors with great clinical treatment difficulties such as small cell lung cancer and pancreatic cancer.
Before founding Phanes, Dr. Wang Minghan has worked in several pharmaceutical companies such as Johnson & Johnson, Amgen, Pfizer, and Gan&Lee. He has gone through the processes of project initiation, R&D, and commercialization of multiple significant disease drugs, possessing rich industry experience. He is also one of the most senior Chinese executives in multinational pharmaceutical enterprises.
"Stories of successful drug development are often written in many books, but the lessons of failure are almost entirely hidden in the historical records of international pharmaceutical giants, inaccessible to outsiders. Yet, this is precisely the kind of critical knowledge that is essential for new drug project initiation." In the 1990s, Dr. Wang Minghan joined the long-established Parke-Davis/Warner-Lambert (later acquired by Pfizer) as a research scientist and eventually became a project leader. Subsequently, he held executive positions at Pfizer, Amgen, and Johnson & Johnson, becoming a core member of various high-level committees within these companies, and reaching the decision-making level in R&D, development, strategy, and commercialization. During this time, he frequently participated in discussions regarding the continuation or termination of new drug development projects. The focus of these strategic discussions was not only on the future clinical value of the pipeline under development but also on reviewing classic failures and successes from the company's long history. Through repeated analysis of real drug development processes, people aimed to uncover overlooked details and identify effective criteria for assessing the risk-benefit of a new drug project.
The twists and turns of these pharmaceutical stories that Wang Minghan heard and participated in had a profound impact on his later formation of an independent entrepreneurial mindset: "You will develop an intuition internally, which can be used to judge the feasibility of projects in their early stages."The first is to avoid homogenization, otherwise it will be difficult to have market potential.This has been repeatedly validated throughout the history of the global pharmaceutical industry and was the first red line established when Phanes Therapeutics, Inc. was founded. In the view of Dr. Minghan Wang, both startup pharmaceutical companies and large pharmaceutical enterprises have their irreplaceable positions in the pharmaceutical industry chain—a rule that has been historically沉淀下来的规律 (historically established). Startup pharmaceutical companies must leverage their differentiated advantages rather than compete on speed in a homogenized market against large pharmaceutical firms.
Before leaving Johnson & Johnson, Dr. Wang Minghan served as the head of the diabetes/metabolic disease field, responsible for Johnson & Johnson's global diabetes drug discovery and Phase I and II clinical development. Many times, he would lead his team in searching globally for innovative drug projects worth acquiring. "In fact, large pharmaceutical companies do not have an advantage over innovative drug companies when it comes to R&D, because it’s difficult for large ships to change course quickly. This is why we often see large pharmaceutical companies expanding their pipelines through acquisitions after reaching a certain stage of development." However, Dr. Wang Minghan gradually discovered that there are not many good projects that can endure the loneliness of developing truly original drugs, which inspired him to start his own company. He wanted to genuinely address issues where there is clinical and market demand but no effective solutions.
According to Dr. Wang Minghan, Phanes Therapeutics starts from clinical needs to pursue differentiated innovation, which means discovering opportunities for innovation in the safety and efficacy flaws of drugs. At the time of its establishment, there were many defects in innovative drugs targeting some emerging targets in the oncology field. For instance, some drugs targeting CD47, while demonstrating significant efficacy, had safety issues. Additionally, many drugs targeting CD73, although relatively safe, lacked thorough mechanistic research and showed suboptimal efficacy. The strategy for Phanes Therapeutics' early pipeline was to address such issues and provide clinically effective solutions.
“For初创 biotech companies, if their pipeline is too focused on basic research, the risks can be significant."This is the second red line for Dr. Wang Minghan in drug development, which means taking into full consideration subsequent preclinical R&D, registration advancement, commercialization, market potential, and other factors right from the project initiation. Each new drug R&D endeavor represents an entirely unknown challenge, even for highly experienced professionals in drug development, but clear top-level design remains indispensable."
If starting directly from the discovery of new targets, it would take at least 2 to 3 years to complete the foundational research on signaling pathways. Emerging biotech companies often lack sufficient funding and resources to support such long-term pure technological research. However, in the long run, any new drug development company needs to build a sustainable competitive advantage based on a high-barrier technology platform.
Dr. Wang Minghan told VCBeat that in the early stages, Phanes Therapeutics did not focus on building a first-in-class pipeline. Instead, it integrated clinically valuable innovations into its best-in-class pipeline. After completing technological accumulation, the company then attempted to construct three world-leading bispecific antibody platforms with strong innovation: PACbody™, SPECpair™, and ATACCbody™. This is no easy feat for a new drug development company.We have invested a significant amount of manpower and time in developing and optimizing the bispecific antibody platform. However, it is difficult for other teams to easily breakthrough with new drugs developed based on this platform, forming a key technical barrier.”
In May 2021, Phanes Therapeutics completed its Series B financing round led by HongShan. With substantial financial support, Dr. Wang Minghan led an efficient and professional team to advance three preclinical projects into the clinical stage within just over a year, by 2022. This marked the transformation of Phanes Therapeutics from a preclinical drug discovery company to a clinical-stage drug development enterprise. For many companies, this transition might have occurred earlier. Phanes Therapeutics spent nearly five years focusing on early-stage research and the construction of its technology platform, and finally reaped the rewards in 2022.
"It took so long to do the R&D, and indeed it was under pressure," said Dr. Wang Minghan. He insisted on settling down to do R&D during the cycle of the explosive growth of innovative drug IPOs.In his view, if the foundation is not solid, innovative pharmaceutical companies will hardly have core advantages to withstand potential industry cycles.Although at every stage of Phanes Therapeutics' growth, Dr. Wang Minghan has brought in top industry experts to lead the team, he still spends a significant amount of time in the lab reviewing data and optimizing solutions. Jokingly, someone once asked why, despite all the research, results were not often seen. Dr. Wang Minghan laughed and replied, "We're just slower, so it takes more time." Behind the humor lies the rigorous approach of a pharmaceutical researcher and a deep respect for science.
Currently, three drugs developed by Phanes Therapeutics, Inc. are advancing in clinical trials at top clinical centers in the United States. Among them, the CD73 monoclonal antibody project PT199 is a best-in-class product with differentiated characteristics; the Claudin18.2/CD47 bispecific antibody project PT886 and the DLL3/CD47 bispecific antibody PT217 are both world-first first-in-class products. Both have received orphan drug designation from the FDA, which will provide strong support for subsequent clinical trials and help accelerate product approval and market launch.
Dr. Wang Minghan told VCBeat that the difficulty in new drug development lies in the fact that every step must be taken with clear understanding, but each project is full of entirely new challenges. Many knowledge points cannot be quickly grasped based solely on past experience. At Phanes Therapeutics, Dr. Wang Minghan organizes his team to brainstorm together, break down unfamiliar problems, determine the required resources, and then connect with corresponding experts. "Even the top experts cannot guarantee that new problems encountered in new drug development can always be solved," emphasized Dr. Wang Minghan. He pointed out that only by thoroughly understanding the ins and outs oneself can external resources be utilized; otherwise, no matter how good the resources are, they will struggle to generate sufficient value.
As self-developed pipelines continue to advance into clinical stages, many biotech companies are facing the challenge of transitioning from biotech companies to biopharmaceutical companies. How does Dr. Wang Minghan think about this issue?
"The transformation from a biotech company to a biopharmaceutical company primarily considers the company's strategy," pointed out Dr. Wang Minghan. Many seemingly difficult-to-break key nodes, under the guidance of an appropriate company strategy, are actually inevitable outcomes of advancing research and innovation. Taking going overseas as an example,In Dr. Wang Minghan's view, as a new drug research and development enterprise, innovation should be global-facing., which needs to be considered from a global perspective from the very beginning. Therefore, even in the early stages of Phanes' development, going overseas was already an important strategic goal.
Since 2019, Phanes Therapeutics has successively reached several out-licensing agreements with Hanmi Pharmaceuticals, Fosun Kite, and a North American Nasdaq-listed company, with a total transaction value of approximately $1.2 billion. Its R&D capabilities have been widely recognized by peers across multiple fields. On March 6 this year, Phanes Therapeutics announced a research collaboration agreement with Xyphos, a subsidiary of Astellas, to utilize Phanes' proprietary technology platform, PACbody.TMand SPECpairTMEvaluation of cell therapy in the field of oncology demonstrates that its bispecific antibody technology platform has globally leading competitive advantages. In addition, after Phanes Therapeutics advances its R&D pipeline to the clinical stage, it will also promote global clinical trials and expand into overseas markets.
For most biotech companies, their products are far from the market, and the team spends a long time buried in the lab. The results they produce may deviate from market expectations. Only by continuously interacting with the market can they ensure that their growing R&D capabilities align with clinical needs. "No matter how early-stage the R&D pipeline is, whether it has licensing potential is a very critical risk control point," said Dr. Wang Minghan. "Only by repeatedly interacting with the market can we get closer to reality, better understand our weaknesses, adjust strategies in time, and ensure the company continues on the path to success."
Second is the flexibility of strategy. When innovative pharmaceutical companies are just starting, cultivating original innovation capabilities is undoubtedly the core task. However, as they enter a new phase as biopharmaceutical enterprises to continue production, corporate strategy must emphasize flexibility even more. A diversified R&D strategy that skillfully combines in-house development with collaborative efforts across different technology platforms and indications will significantly enhance operational efficiency. There is no doubt that seeking strategic partnerships and multi-faceted licensing will be an essential part of Phanes Therapeutics' future development strategy.
Dr. Wang Minghan told VCBeat that he plans to introduce collaborators in the Phase II clinical trials of PT886 and PT217, integrating each other's strengths to accelerate the clinical application of these two original innovative drugs. "Once our original innovative drugs enter the fast track of Phase II clinical trials, Phanes Therapeutics will have taken another big step towards becoming a biopharmaceutical company. We also look forward to more original innovative drugs developed by teams in China reaching the global stage, providing newer and better solutions for clinical practice."

Although Phanes is a transliteration of the English word “Phanes,” it also carries the寓意of "ordinary people, bringing grace to the world." In ancient Greek mythology, “Phanes” is a deity who brought light and life to the world. This aligns perfectly with Dr. Wang Minghan's determination when he founded Phanes Therapeutics, Inc., to bring hope of light and life to cancer patients through innovative drug research and development.