When we talk about "Great Power New Drugs," what exactly are we trying to discuss?

 

It is not about the sales figures of another blockbuster drug, nor the upfront payment of yet another overseas licensing deal, not even the share of Chinese pharmaceutical companies in the global pipeline. These are all important, but they belong to the level of "tactics."

 

The "greatness" of "Great Power New Drugs" lies not only in the size of the market, but more importantly in the strategic vision and the sense of responsibility.

 

Today, China, as a responsible major power with a population of 1.4 billion, is moving to the center of the world stage. It has begun to export its own standards in areas such as high-speed rail, new energy vehicles, photovoltaics, drones, and electronic communications. So, in the special field of "pharmaceuticals," which concerns national health and global public welfare, how can China's pharmaceutical industry establish its due "voice"?

 

At the end of May, focusing on the core top-level propositions of the future of Chinese medicine, the setting of rules for pharmaceutical innovation, and the construction of a voice, Cheng Zengjiang, Founder/Chairman of TONACEA, held a strategic conversation with Zhu Xun, Founding Chairman of the TONACEA New Drug Talents Club, aiming to chart the course for "Great Power New Drugs."

 

Two years ago, Zhu Xun sharply pointed out: "The problems currently facing China's innovative drugs cannot be solved within the pharmaceutical industry alone."

 

Over the past few years, while calling for industry unity to create a favorable environment for the healthy development of biotechs, he has also tried to step outside the pharmaceutical circle to "raise the dimension" and find a way to break the deadlock in China's pharmaceutical innovation.

 

He visited several countries such as Egypt and Malaysia, inspecting local pharmaceutical markets and meeting with high-level officials such as ministers of health and heads of drug regulatory agencies, trying to find new paths for Chinese innovative drugs to go global. However, although there is significant demand in these countries, the matter is not as simple as matching supply and demand.

 

He said we must clearly recognize that drugs are special commodities. Their distribution is highly dependent on prior approval and cannot directly enter third-party countries through market mechanisms.

 

Zhu Xun believes that to resolve this prerequisite, we must ultimately return to the game of standards, technology, and voice, and this must be done at the national and governmental levels.

 

In his view, China's pharmaceutical industry has reached a critical turning point of "strategic standoff." Over the past decade, relying on the "Chinese consumption" market, a vast engineering dividend, and a flexible "fast-follow" strategy, we have completed the foundational industrial accumulation and, with an "R&D story" posture, initially ascended the world stage through BD (out-licensing).

 

However, relying solely on the internal cycle of the pharmaceutical circle, on me-too improvements, fast follow, and on "selling" product rights to multinational giants cannot support a truly globally influential industry of a major power.

 

In his view, China's pharmaceutical industry must step out of its "comfort zone," draw on the successful experiences of China's high-speed rail, new energy vehicles, and other fields, and "as soon as possible cultivate several enterprises with international influence!"

 

At the same time, in emerging therapeutic areas and fields where China has significant advantages, we must take the initiative to establish and promote "Chinese standards," breaking free from the inertial dependence on past regulatory paths, and ultimately using these "sparks" to connect into a surface, truly winning a voice commensurate with China's status as a great power.

 

TONACEA 01: Strategic Standoff Under Internal and External Pressure

 

At the end of May, with the opening of the 2026 ASCO (American Society of Clinical Oncology) Annual Meeting, the innovative drug capital market once again presented puzzling fluctuations.

 

At the ASCO conference, Chinese biomedical projects made密集 and high-profile appearances, with clinical data attracting the attention of international peers. In stark contrast, however, the stock prices of related enterprises in the capital market continued to fall.

 

Extending the timeline slightly further, since falling from the previous peak at the end of September 2025, the Hang Seng Biotechnology Index has fallen by more than 50% over nine months.

 

Zhu Xun is no stranger to this scene. Having been with China's biomedical industry through its ups and downs for over thirty years, he has seen too many such moments.

 

"The entire biotech investment has shifted from telling an R&D story to telling a profitability story." Zhu Xun pointed out that the secondary market is no longer willing to pay for purely R&D stories. Even if companies announce good subsequent clinical data, the capital market基本上 responds with negative results, indicating that investors are重新审视 the intrinsic value of innovative drugs.

 

And the foundation of the profitability story must be "good products" and "good companies." Since the end of 2018, he has repeatedly emphasized that the success of a Chinese biotech is not having a nice team, a nice pipeline, or even a stock market ticker, but that the product enters the market, gains market share, and generates sales revenue and profit.

 

In his view, China's pharmaceutical industry has now reached a critical turning point of "strategic standoff," and the internal and external environment has changed dramatically.

 

Over the past decade or so, with policy breakthroughs, easy financing, accelerated industry growth, and original innovation still in the "low-hanging fruit" stage, China's innovative drugs, relying on the "Chinese consumption" market, a vast engineering dividend, and a flexible "fast-follow" strategy, have formed industrial accumulation from 0 to 1 and completed the laying out of the "R&D story."

 

But the capital market can reward stories for a period of time, but it cannot forever replace the industrial market in delivering results. Once stories run out, or capital is no longer willing to pay for the next round of imagination, companies that have not yet achieved commercialization or profitability will fall into difficulty.

 

China's innovative drug industry cannot always remain at the stage of R&D, transactions, and investment stories, with companies fleeting. It must eventually realize the commercial closed loop, and there must be several truly good companies that stand firm – the delivery of the profitability story brooks no delay.

 

Even more concerning is that several recent negative policy signals are substantively compressing the industry's survival and room for imagination.

 

Domestically, under a single-payment system, innovative drugs struggle to achieve reasonable returns, "involution" is intensifying, and the recent biosimilar centralized procurement plan is being implemented, continuously compressing the market space for innovative drugs. At the same time, there are rumors that some ministries are discussing the introduction of policies that may restrict the external cooperation and transfer (BD) of early R&D projects.

 

Externally, a Republican congressman first requested, on "national security" grounds, that the FDA refuse to accept, review, or even consider Chinese clinical data when pharmaceutical companies submit IND applications. Then, another proposal proposes to include biotechnology within the prohibited investment scope of the COINS Act, restricting the flow of U.S. capital and intellectual property into China's biotech sector.

 

With internal and external pressures intertwined, the traditional development paths of China's pharmaceutical industry are being narrowed one by one.

 

But Zhu Xun believes that external pressure is not entirely negative. On the one hand, it conversely proves that China's pharmaceutical industry has reached a strength that makes rivals wary. On the other hand, it also provides a possibility to break the long-standing inertial dependence on the U.S. FDA system.

 

This reverse pressure is pushing China's pharmaceutical industry to a point where it must make its own choices.

 

TONACEA 02: Batch Going Global of "Made in China" Pharmaceuticals

 

Throughout his thinking, Zhu Xun has always had a clear logical thread that runs through: Chinese pharmaceutical innovation should be a symphony of three major acts – "Chinese Consumption – Made in China – Created in China." New drugs created in China should both satisfy Chinese consumption and go global through Made in China.

 

At present, in terms of "Chinese Consumption," drug accessibility has been achieved, but the expected commercial benefits have not been generated. As for "Made in China," over the past 30 years, "Made in China" can be seen in almost every field, including LCD panels, batteries, mobile phones, electric vehicles, drones, etc., but "Made in China" in the pharmaceutical field has noticeably fallen behind.

 

In Zhu Xun's view, the various products labeled "Made in China" or "Manufactured in China" that are found around the world have, without exception, undergone the honing of Chinese consumption before gradually entering the stage of Made in China. Following this logic, after generics have undergone一致性评价 and national centralized procurement, and after large numbers of biosimilars have been used by Chinese patients, the going global of "Made in China" pharmaceuticals must be realized.

 

He believes there are three main categories of players for "Made in China": chemical generics (APIs, formulations), biosimilars, and fast-follow and me-too drugs.

 

The specific implementation path is: first, through the consumption of China's 1.4 billion population to hone the capabilities of Chinese pharmaceutical companies, enabling these three categories of drugs to reach international quality levels and minimize production costs. Once the competitiveness and reputation of "Made in China" pharmaceuticals are established, opportunities for Chinese pharmaceutical companies to break into international markets will arise – this is the path that can enable China's pharmaceutical industry to achieve rapid development in the coming period.

 

Following this thread, over the past few years, he has visited multiple countries and regions around the world, not only observing the pharmaceutical industry itself but also more concretely comparing the going global paths of other Chinese industries.

 

In Egypt and Malaysia under the "Belt and Road" initiative, facing the heads of drug regulatory authorities, he proposed a plan: select biologics that have been marketed in China for three years, with fully guaranteed safety and efficacy. He requested that the local authorities open a fast-track channel: with all documents complete, simply conduct a bridging study of 20–30 cases locally, with rapid approval in about six months. Regarding pricing, supply at 1/30 to 1/10 of the U.S. market price, even provide bottled finished products for local relabeling.

 

The demand is real and existing, and the space is sufficiently large, but the responses were almost identical: if approved by the FDA, it could be considered; if not approved by the FDA, a full clinical trial must be conducted again.

 

This is less a matter of technology and quality than an understanding of regulatory path dependency. "Pharmaceuticals are special commodities for any country, with prior approval and market access. But there is currently no other type of product globally that has such a hard standard as the FDA, even exceeding the status of the U.S. dollar. Many countries don't use the dollar, but they recognize the FDA's drug standards."

 

Therefore, Zhu Xun repeatedly emphasizes that the problems currently facing China's innovative drugs cannot be solved within the industry alone. He says, "Many things cannot be resolved within the pharmaceutical circle. Resolution within the circle is only a partial event and cannot solve the big problem."

 

How to truly realize the batch going global of Chinese pharmaceuticals and, like other industries, complete the key export from "Chinese Consumption" to "Made in China"? Zhu Xun believes this requires the intervention of government power, such as leveraging "Belt and Road" related policies to enter these countries.

 

The specific vision is to simultaneously convene a health sub-forum during the Belt and Road Forum for International Cooperation, inviting heads of state, heads of drug regulatory agencies, and ministers of health from participating countries to visit on-site China's drug review agencies and manufacturing enterprises, enhancing understanding and trust in China's regulatory capabilities.

 

"Once you have that first top-level government exchange, it creates a guiding effect, and things will flow more smoothly afterward." Zhu Xun has previously submitted systematic proposals to the state through certain provincial and municipal government channels, hoping to realize this vision.

 

Furthermore, there is a key step: "China should as soon as possible produce several giants that can gain a place internationally." Zhu Xun emphasizes.

 

Any industry's global standing requires benchmarks. For example, Huawei enjoys a worldwide reputation, and BYD has orders queued for over a year in Australia. The same applies to pharmaceuticals. China's international standing in the pharmaceutical industry is reflected to some extent in its representative companies. China needs several pharmaceutical giants with international influence.

 

Zhu Xun says the current leading companies are still engaged in involution – piling up pipelines, engaging in "question bank tactics." They lack not money or technology, but strategic resolve and global ambition. They must accelerate cultivation through M&A integration and overseas布局. Without giants, there is no voice.

 

In April, the largest overseas acquisition in the history of the Indian pharmaceutical industry was finalized – Sun Pharma acquired U.S. drugmaker Organon for US$11.75 billion in an all-cash transaction. Zhu Xun reminds that this transaction is a transformation sample worth paying attention to for domestic pharmaceutical companies. "Look at which global large pharmaceutical company has grown through BD and out-licensing? A significant portion of global large companies have developed through M&A. China's next step must be to take the path of M&A."

 

TONACEA 03: Building Chinese Standards and Voice

 

Manufacturing going global addresses matching supply and demand and market access. Cultivating giants addresses industrial scale and global voice. But the real "path" must ultimately rest on the construction of a system of standards and voice.

 

Whoever controls the standards controls the access threshold and competitive rules of the global pharmaceutical industry.

 

The FDA built a globally recognized review system over more than half a century, not because its science is impeccable, but because the United States dominated the rule-setting for global pharmaceutical trade after World War II. This is not a technical issue; it is a historical issue, and even more so a strategic issue.

 

Today, China's high-speed rail, new energy vehicles, photovoltaics, electronic communications, and other industries can occupy a place globally not only because of cost-effectiveness but also because behind them there is a set of Chinese standards that have been validated by the market and accepted by global users.

 

The same applies to pharmaceuticals, but with a significant difference: the formation of pharmaceutical standards is not a natural result of market choice. It is both a concentrated embodiment of scientific evaluation and principles and a deep contest of voice between different countries and global rules.

 

Zhu Xun believes that if China's pharmaceutical industry truly wants to win a voice, it cannot forever be an "honor student" under the FDA system. It must take its own path, taking the initiative to establish and promote "Chinese standards" in emerging and advantageous fields – just as China has done in electric vehicles, photovoltaics, and other fields.

 

"For traditional small molecules and large molecules, we don't have much room to maneuver," he further analyzed. "But in fact, U.S. standards are incomplete in some areas. And our opportunity lies precisely in emerging therapies and fields where China has significant advantages – in these fields, China's innovation capabilities are fully comparable to those of the U.S."

 

There are quite a few such breakthrough areas, and Zhu Xun summarizes them in several aspects:

 

• Cell and Gene Therapy (CGT): Blockbusters are beginning to emerge internationally. China is looser than the U.S. in terms of IIT (investigator-initiated trials), has abundant patient resources, and has accumulated a large amount of data and experience. With the translation of new technologies under Decree No. 818, China's speed of development and degree of system perfection in this field have formed significant advantages.

• Radiopharmaceuticals: China is a nuclear power. The review logic for radiopharmaceuticals involves special dimensions such as radionuclides and dosimetry, making this a highly individualized field. Future approval of radiopharmaceuticals will not be approving one drug but approving a system – medical radionuclides are a shared foundation, and with different lead compounds, multiple products can be derived, significantly shortening R&D cycles. From this perspective, the future development space for radiopharmaceuticals may not be smaller than that of ADCs.

• Live Biotherapeutic Products (LBP): Although the U.S. has issued guidelines, it has not yet approved a single drug. However, the first product in China filed under the new standards (a product of Suzhou Osaid Pharma) has already entered the NDA stage and is estimated to be approved soon. For complex diseases related to metabolism and degeneration, LBPs can be addressed through intestinal regulation. Currently, the U.S. standard boundaries are very unclear, and this is China's opportunity.

• Therapeutic Vaccines: China is already the largest user of prophylactic vaccines globally. Therapeutic vaccines, particularly individualized therapeutic vaccines, have enormous future development potential. However, review standards, clinical trial paths, and other aspects have not yet formed industry consensus or guidelines.

• Biosimilars: More than 150 antibody drugs have been approved globally, with sales exceeding US$300 billion. Due to the patent cliff and high prices, biosimilars will be the main varieties widely used in the future. China will begin centralized procurement of biosimilars this year, with eight varieties initially finalized, and 40-50重磅 antibody drugs to enter centralized procurement over the next five years. Therefore, taking the lead in exploring the technical standards, process specifications, and quality inspection plans for the conversion from biogenerics to biosimilars will be a major opportunity for China to achieve leapfrog development in the biopharmaceutical field.

 

In these fields, China has either formed significant advantages or is just at the starting line. Together, they point to a possibility: China does not have to follow step by step within the already entrenched standard system of the FDA, but can be the first to define the rules on new tracks where rules have not yet been set. This is not about challenging anyone, but about providing a new option for global pharmaceutical governance – a more affordable, more accessible option contributed by Chinese wisdom.

 

TONACEA 04: The Era's Question to Great Power New Drugs

 

We are fully aware that this is not a proposition that can be solved overnight. The establishment of institutional trust, the accumulation of industrial capacity, the game of geopolitics – each requires the accumulation of time and countless specific and unremitting efforts. Five years, ten years, or even longer.

But precisely because of this, it is even more necessary to raise the proposition of "Great Power New Drugs" today – at a time when the internal and external environments are undergoing dramatic change. Not to find an answer immediately, but to initiate a necessary reflection: can there be another possibility for Chinese medicine?

 

We are not eager to replace anyone, nor do we intend to overturn any mature system. We simply believe that on the map of global pharmaceutical governance, there should be a voice from China, a standard option based on Chinese practice – this is the posture that a responsible major power should have.