Indeed, China's innovative drugs are no longer what they used to be.

Whether it's the increasing number of early-stage research and development pipelines, the record-breaking amounts of overseas licensing deals, or the rising proportion of oral abstract presentations at top international academic conferences, all these factors have filled the entire industry with optimism. Some even argue that "China's innovative drugs have already lived up to China's status as a major country.".

Driven by the collective excitement in the industry, Dr. Cheng Zengjiang, the founder of Tongxieyi, engaged in an in-depth dialogue with Professor Li Jin, the president of Shanghai Gaobo Cancer Hospital affiliated to China Pharmaceutical University and the chairman of the Federation of Asian Cancer Organizations (FACO).

As a landmark figure in China's clinical research field, Professor Li Jin did not cater to this widespread optimism. In his view, a simple yardstick can test this claim: none of the top 20 biopharmaceutical companies in terms of global sales comes from China. He said that true power status cannot only be judged by the bustling R&D pipeline, but also by the industrial scale at the end and the global market discourse power.

Acknowledging progress is as important as recognizing gaps.

01、Partial prosperity

In recent years, "more, faster, better, and cheaper" has become the hallmark of innovative drug research and development in China. Professor Li Jin has dissected each of these four aspects. He believes that "more, faster, and cheaper" are facts, but there is a big question mark over the "better" aspect.

It is a consensus among international peers that China boasts the fastest pace of clinical research globally. The average completion time for Phase I clinical trials in China is one year, whereas it takes 2-2.5 years in the United States. Li Jin attributes this efficiency to three factors: a vast patient base, subjects with generally higher educational levels, and the overburdened efforts of the doctor community.

"A vast amount of clinical research case records, adverse event logs, and follow-up data are all entered word-for-word by young resident doctors and attending physicians. They arrive at work at seven in the morning and leave at eight or nine in the evening," Professor Li Jin lamented. "The treatment and compensation for medical students in China are seriously mismatched with their efforts. A large number of medical talents are flowing to positions such as pharmaceutical company representatives, which is a social waste.".

But can the speed continue to increase? Professor Li Jin's answer is "it is already close to the limit".

Scientific laws set hard boundaries. In a typical dose escalation design, each dose step usually requires observation for 28 days, and a minimum of four steps amounts to eight months. Coupled with patient screening, baseline examination, and enrollment procedures, a year is already the limit. If the sponsor requires the dose escalation to be completed within eight months, it is not collaboration but a violation of the basic logic of risk control. Just like a 100-meter sprint, there is always an unbreakable limit time.

Professor Li Jin adopts a more cautious criterion for "good". The proportion of oral presentations given by Chinese researchers at major international academic conferences such as ASCO, AACR, and ASH has been increasing year by year, approaching 30% in some fields. This, to some extent, reflects the level of activity in early-stage clinical research in China. However, he believes that this indicates more about quantitative growth rather than absolute quality leadership.

"True 'excellence' refers to a product that can establish treatment standards globally and become the preferred option among similar therapies. Judged by this standard, there are still only a handful of Chinese innovative drugs that truly achieve global leadership.".

Professor Li Jin cited bispecific antibody (BsAb) products as an example: according to the strictest benchmarking approach, BsAbs should demonstrate superior efficacy in a "head-to-head" comparison with the combination therapy of two corresponding monoclonal antibodies (mAbs) to constitute a true breakthrough. Currently, most products have not yet reached this standard. Although some studies show good progression-free survival, the overall survival benefit is not significant, largely due to the disadvantage brought by the target depletion effect in later-line treatment. Therefore, while the cutting-edge data and preliminary efficacy are commendable, it is not appropriate to equate them with "good" too early.

"Just because a county has produced a student from Tsinghua University doesn't mean the entire county's education level is the best in the world." Similarly, the outstanding performance of a few products cannot mask the lack of overall leadership ability.

02、"Creation" is missing

The research and development of innovative drugs in China is often criticized for "involution". Once a target emerges, hundreds of companies flock to it. Professor Li Jin observed that the situation has slightly improved in the past two years, and the rationality of the industry has increased, but the basic pattern of involution has not fundamentally changed.

"Everyone is accustomed to fast follow-up," Professor Li Jin pointed out. The number of biopharmaceutical companies in China far exceeds that in the United States, and a large amount of resources are concentrated on a few validated targets. Once there is a positive signal in a certain direction, a large number of similar projects will quickly follow suit.
The deeper reason lies in the absence of a mechanism for industry consolidation and restructuring. There are over 14,000 biopharmaceutical companies in China, yet there are very few mergers and acquisitions among them. This is partly related to the deeply ingrained cultural belief of "preferring to be the head of a chicken than the tail of a phoenix". At the same time, there is room for further improvement in the country's top-level design for differentiated guidance towards truly innovative targets and improved products.

However, what worries Professor Li Jin even more is the gap in core driving forces for China's pharmaceutical innovation. He has repeatedly emphasized a viewpoint on multiple occasions: China is active in innovation, but lacks in invention.

"Innovation is about making existing things better, moving from having to excellence; while creation is about going from scratch, developing products that have never existed in the world before." Currently, many mainstream technological routes being researched in China, ranging from monoclonal antibodies, bispecific antibodies to ADCs, mostly originate from scientists in the United States, Japan, and other countries. He admitted that Chinese companies are very capable in engineering transformation and clinical development, but their contributions to defining new targets and treatment paradigms are still very limited.

Regarding how to achieve genuine original innovation, Professor Li Jin proposed a specific approach: focusing on signal pathways. Taking KRAS and its upstream and downstream pathways as an example, he raised the question of whether AI could be utilized to screen a brand-new molecule from a vast molecular library, capable of simultaneously inhibiting three to four upstream and downstream targets such as EGFR, KRAS, and BRAF, with a therapeutic effect superior to that of the combination of inhibitors targeting these targets.

If such a drug can be developed, it will signify the establishment of a brand-new treatment paradigm globally, representing a quintessential "creation" from scratch. China's AI technology and high-throughput screening capabilities are already equipped to support such explorations. The key lies in whether the research and development team has the courage and determination to challenge this long-cycle, high-risk yet immensely valuable direction.

03、 Foundation, determination, and "mutual pursuit"

Despite maintaining a calm and critical attitude towards the current situation, Professor Li Jin still has confidence in the quality of clinical research in China.

After the "722 Storm", China's quality control system for clinical research underwent a systematic restructuring, and large hospitals have significantly increased their emphasis on research quality. This serves as the institutional foundation for obtaining international recognition for the data.

He revealed that the recognition of the quality of clinical research in China by international peers, even the US FDA, has seen a substantial improvement. Taking the example of Hehuang Pharmaceutical's fructinib, the efficacy data from its phase III clinical trial completed in China ten years ago are highly consistent with the results of repeated clinical studies conducted in the US and Europe many years later, with no significant differences observed in response rate, progression-free survival, or overall survival.

Regarding the recent remarks made by some US lawmakers proposing restrictions on the use of Chinese clinical data, Professor Li Jin believes there is no need for excessive interpretation or panic.

Firstly, it will take a lengthy legislative and administrative process, lasting at least three years, for relevant proposals to evolve into formal regulatory guidelines. Secondly, cooperation between China and the United States on drug evaluation data is reciprocal. If the United States sets up barriers, China also has the policy space to respond in kind. "If the United States cannot use Chinese data, China can also refrain from using American data. This is called reciprocity."

The world is vast enough to accommodate both China and the United States. What truly leads to confrontation is when one side believes it can win without suffering any losses. When both sides realize that a "duel" means mutual destruction, rationality will return.

China has a population of 1.4 billion, boasts the world's largest unified market, and is home to the world's most diligent doctors and scientific researchers. Chinese innovative drugs will not be hindered by any external restrictions. Maintaining strategic focus and doing our own thing well is the most effective way to respond.

Regarding the recent record-breaking transaction volumes of Chinese innovative drugs in their BD (business development) overseas expansion, Professor Li Jin stated that he does not predict trends, but rather pays more attention to the industrial hierarchy reflected by overseas expansion.

Throughout his career, Professor Li Jin has participated as a principal investigator in multiple early-stage clinical projects that ultimately achieved overseas licensing. He is well aware of the supportive role of high-quality clinical data in deal negotiations, and the research quality in China has gained the trust of multinational giants such as Merck & Co. However, he emphasizes that BD going global is only an intermediate state for Chinese innovative drugs to reach the world, and should not be regarded as the end point.

The true rise of an industry signifies that Chinese enterprises are no longer merely exporters of products. It means that China has given birth to its own multinational pharmaceutical companies, which have entered the top ten in global sales and possess the capability to integrate innovative resources worldwide.

On that day, we can truly say that "China's innovative drugs are worthy of its status as a major country".