Just having received 200 million in financing, this innovative drug company wants to list in Hong Kong.

Text | Hu Xiangyun

Editor | Hai Ruojing

The enthusiasm of innovative pharmaceutical companies to flock to the Hong Kong stock market continues. YingShi Biopharm, which recently submitted its listing application, is one of them.

Founded in 2017, YingShi Biopharm focuses on the R & D of new anti - cancer drugs. Its founder, Wang Zaiqi, is a veteran in the pharmaceutical industry. Before starting his business, he had been working in multinational pharmaceutical companies such as Eli Lilly, Merck & Co., and Roche, leading the development of more than 20 new drug molecules at home and abroad. Wang Zaiqi led the clinical R & D and marketing of Merck's well - known quadrivalent HPV vaccine and the PD - 1 drug "Keytruda", which has topped the global sales list in recent years, in the Chinese market.

After leaving to start his own business, Wang Zaiqi didn't choose a popular target or indication area as most innovative pharmaceutical companies did at that time. Instead, he was determined to start from a more fundamental level and target the "drug resistance" problem that exists in almost all types of cancers and anti - cancer drugs.

In Wang Zaiqi's view, this will be the "ultimate" market after the popularization of immunotherapy and targeted therapy. Therefore, if the drug resistance problem of blockbuster drugs can really be solved, theoretically, more cancer patients can benefit from existing treatment methods, which naturally corresponds to a larger market space.

Perhaps it is this vision that has attracted a group of capital backers for YingShi Biopharm. Before going public, the company had completed six rounds of financing totaling $130 million, and its post - investment valuation after the Series C round was $306 million. The investment institutions include SDIC Capital, FJ Capital, Bixin Ventures, and Enran Ventures.

It is understood that as early as 2023, YingShi Biopharm had started preparations for listing. However, affected by the policy changes at that time, the listing channels for unprofitable biopharmaceutical companies in the domestic market were blocked, and many of them broke their issue prices. But this year, as the market has recovered, 60 healthcare companies have submitted listing applications to the Hong Kong Stock Exchange, with innovative pharmaceutical companies accounting for more than 50%. More than 10 new drug companies have successfully gone public, and many of their new shares have doubled in market value.

After years of preparation, will YingShi Biopharm be the next one?

Targeting the "drug resistance" problem

Betting on a target that multinational pharmaceutical companies failed on

The "drug resistance killer" that YingShi Biopharm is betting on is a small - molecule FAK inhibitor.

FAK is called focal adhesion kinase. As early as the beginning of this century, the pharmaceutical industry had started clinical research on FAK inhibitors. Pfizer, GlaxoSmithKline, Boehringer Ingelheim, etc. had all made attempts. At that time, multinational pharmaceutical companies mainly conducted single - drug research on it as a targeted drug, and the results were not satisfactory. It is reported that between 2005 and 2018, at least five FAK inhibitors were terminated due to poor efficacy.

However, in Wang Zaiqi's view, the problem may not lie in the target itself, but that scientists were looking in the wrong direction. So, when starting his business, he bought the FAK inhibitor that Boehringer Ingelheim had abandoned and began new research. This is now the core product of YingShi Biopharm, Ifebemtinib.

Source: Prospectus of YingShi Biopharm

However, YingShi Biopharm didn't spend time on the single - drug development of FAK inhibitors. Instead, it saw the potential of FAK inhibitors to "assist" in solving the drug resistance problem of other drug molecules and better exert the therapeutic effect.

The drug resistance problem is very common. Take the broad - spectrum "miracle anti - cancer drug" PD - 1 for example. It can only achieve a response in about 30% of patients, and the other patients who don't respond belong to the group with primary tumor drug resistance. According to the data in the prospectus, 80% - 90% of cancer patients will eventually die due to drug resistance problems.

Fundamentally, the emergence of drug resistance is related to the defense mechanism that tumors "actively" evolve to resist various external drugs that kill them. The emergence of this mechanism is closely related to FAK. In the human body, it mainly plays a role in cell signal transduction and is responsible for regulating cell growth, embryonic development, tumorigenesis, and migration. Therefore, if this mechanism can be destroyed by inhibiting FAK, theoretically, it will be "unimpeded" to kill tumor cells later.

Based on this understanding, YingShi Biopharm began to explore the potential of Ifebemtinib in multiple tumor indications such as ovarian cancer, non - small cell lung cancer, and colorectal cancer. Among them, the research on ovarian cancer has made the fastest progress.

At present, the most effective treatment for this disease is platinum - based drugs, but most patients will eventually develop drug resistance. A R & D person from a pharmaceutical company introduced that after platinum resistance occurs, the effect of switching to other chemotherapy regimens for patients is very limited. The objective response rate (ORR) is often just over 10%, and the progression - free survival (PFS) and overall survival (OS) are only about 3 months and 12 months respectively. "In recent years, although products such as PD - 1 and ADC have been explored as single drugs or in combination, either the effect is average, or the patient population that can be covered is limited."

In contrast, the combination therapy of Ifebemtinib has shown a stronger therapeutic effect than existing therapies. A previous Phase Ib/II clinical trial showed that the ORR of Ifebemtinib in combination with chemotherapy for platinum - resistant recurrent ovarian cancer was 40.7%, and the median progression - free survival (mPFS) and median overall survival (mOS) reached 7.5 months and 20.9 months respectively.

Benefiting from this, this product has successively obtained the Fast Track designation from the US FDA and the Breakthrough Therapy designation from the National Medical Products Administration of China. The prospectus states that Ifebemtinib is expected to submit a listing application for the treatment of ovarian cancer in China by the end of this year or early next year.

Great potential in combination therapy, may boost commercialization

Since its establishment, YingShi Biopharm has not achieved profitability. During the first quarters of 2023, 2024, and 2025, YingShi Biopharm's operating losses reached 174 million yuan, 143 million yuan, and 27.5 million yuan respectively. However, as Ifebemtinib gradually enters the commercialization stage, this situation may change.

However, as a "non - druggable target" for a long time, FAK inhibitors are still a new thing in the field of tumor treatment. It was not until May this year that the FDA approved the first FAK inhibitor for the treatment of ovarian cancer to be listed. There is no relevant product approved in China, and the number of companies in research is not large.

This also means that as a "pioneer", YingShi Biopharm may need to pay a higher cost for market education. According to the prospectus, since 2022, YingShi Biopharm has started preparations for commercialization. It has now established a sales team of 22 people and has established cooperation or contact with top - tier hospitals such as the Cancer Hospital of the Chinese Academy of Medical Sciences in previous clinical studies. It is also considering "cooperating with mature CSOs".

It is worth mentioning that in this process, the potential of FAK inhibitors in combination therapy may, to a certain extent, boost its commercialization. The aforementioned R & D person believes that the characteristic that FAK inhibitors are more suitable for combination therapy scientifically determines that their mechanism does not conflict with various mature therapeutic drugs. Therefore, "they may not form competition but a synergistic relationship."

According to the prospectus, FAK inhibitors have shown "synergistic potential" in combination with chemotherapy, targeted therapy, immunotherapy, and even some new therapies. Take ADC, a popular new therapy nowadays, for example. Its principle is to improve the accuracy and persistence of treatment by realizing targeted payload delivery and regulating the tumor microenvironment. After being combined with FAK inhibitors, it "can further expand the therapeutic window and enhance the efficacy in various scenarios", laying the foundation for it to become the next - generation basic therapy.

Specifically in the treatment field, in the ovarian cancer indication, YingShi Biopharm has an advantage in progress, but the market is relatively small, with about 60,000 new patients each year.

In contrast, the key point to watch for FAK inhibitors in the future may be in lung cancer. As a recognized "major cancer type", the annual new incidence of lung cancer is close to 900,000 cases. However, in this indication, the progress of the companies that have already entered the field is very competitive.

In October 2024, APG - 2449, a triple inhibitor of ALK/FAK/ROS1 from Ascentage Pharma, entered Phase III clinical trials. The ORR for treatment - naive ALK - positive non - small cell lung cancer reached 78.6%, and the ORR for patients resistant to second - generation ALK inhibitors was 45.5%.

It was not until August this year that Ifebemtinib launched its first Phase III clinical trial for non - small cell lung cancer. Slightly different, it targets patients with KRAS G12C mutation - positive, and the ORR in the previous Phase Ib/II clinical trial was 87%. The prospectus states that this indication is expected to be completed by 2027.

Next, whoever can get approved first may also determine who can become the preferred partner for existing mature tumor therapies in combination treatment.