Recently, Yangcheng Evening News published an article titled “Guangdong’s Innovative Drugs Strive to Break Through in R&D Translation, AI Empowerment and Other Tracks, Continuously Enhancing Global Competitiveness! Writing ‘Made in Guangdong’ onto the Instructions of Innovative Drugs.” Let’s take a look together!

Guangdong’s innovative drugs are stepping onto the world stage.

By the end of 2025, China had a total of 4,751 innovative drugs under research, accounting for 33.7% of the global total and ranking first in the world. In 2025, the National Medical Products Administration approved 76 Class 1 innovative drugs for the whole year, a record high. In this leap forward, Guangdong is one of the most active regions—in 2025, Guangdong approved 8 Class 1 innovative drugs; in the first half of 2026, this number had already reached 6.

In Guangdong, a group of traditional pharmaceutical companies are transforming, and a group of innovative pharmaceutical companies are seeking new breakthroughs. The era of “following others” has passed, and there are more and more stories of “being the first to do it.”

Daring to Gnaw on the Hardest Bones

“At present, globally, Yipinhong’s AR882 is the first oral small-molecule drug under research that has completed Phase III clinical trials and can dissolve gout tophi.”

Yipinhong is a pharmaceutical company established in Guangzhou in 2002, starting with pediatric drugs and chronic disease generics. After listing in 2017, Yipinhong clearly took “global new” as its core strategy. In 2025, its independent R&D investment exceeded 200 million yuan, accounting for 21.67% of revenue.

“Transforming into an innovative pharmaceutical company faces three major difficulties. The first is funding: innovative drug R&D requires high investment and long cycles. The second is technology: crossing from traditional imitation to original drugs has an extremely high threshold. The third is talent: top scientific research, clinical and commercialization talent are scarce resources,” said Zhang Mingyuan, board secretary of Yipinhong.

But Yipinhong chose to gnaw on the hardest bones, charging toward “gout,” which is called “one of the arthritis types with the highest degree of pain,” and initiated AR882—a potent and highly selective URAT1 inhibitor. Zhang Mingyuan introduced that AR882 improves safety through deuteration, is administered once daily, and its efficacy covers 24 hours. In 2024, AR882 received Fast Track designation from the U.S. FDA. In 2026, the domestic Phase III clinical trial reached its primary endpoint.

“Next, the company will advance registration applications and commercialization preparations according to plan, striving to bring it to market as soon as possible to benefit patients,” said Zhang Mingyuan.

Akeso Biopharma chose another path. In 2012, Xia Yu and three partners founded Akeso Biopharma in an inconspicuous laboratory in Zhongshan. In the early days of the company, when global pharmaceutical companies were rushing to follow the PD-1 monoclonal antibody trend, the Akeso team decided to bet on “dual targets,” relying on its independently built Tetrabody bispecific antibody technology platform to initiate cadonilimab and ivonescimab.

Ten years later, these two drugs became the world’s first tumor immunotherapy bispecific antibody new drug and the world’s first bispecific antibody new drug with a “tumor immunity + anti-angiogenesis” synergistic mechanism, respectively. In September this year, ivonescimab defeated the global “drug king” pembrolizumab head-to-head as a monotherapy in a Phase III study.

Moving Up the Industrial Chain

The success of one innovative drug may be accidental, but the emergence of a batch of innovative drugs requires soil capable of self-circulation.

Liu Jian, strategic scientist of Guangzhou Pharmaceutical Holdings, said that Guangdong has dense clinical resources. Guangzhou alone gathers dozens of Grade 3A hospitals, and a large number of real clinical scenarios have become the core touchstone for innovative drugs.

At the same time, Guangdong’s pharmaceutical development relies on its industrialization foundation and continues to move upstream in the chain—transformation institutions, pilot testing platforms, and proof-of-concept funds are densely landing, further opening the key path from laboratory to production line.

“Having resources but no system to undertake them is like having good ore in the mountains but no road; the ore cannot be transported down.” Liu Jian believes that from scientific discovery to creating a product, there is still a long distance of industrialization, commercialization, and clinical demand in between. Only when enterprises participate can a closed loop of R&D, production, and sales be achieved.

As a chain-leading enterprise in biomedicine at the provincial and municipal levels, Guangzhou Pharmaceutical Holdings led the construction this year of the National University Biomedical Regional Technology Transfer and Transformation Center, selecting 33 cutting-edge projects from more than 800 university projects nationwide. “We are solidly building a public transformation bridge that can undertake achievements from universities nationwide and connect the innovation chain, industrial chain, and capital chain,” Liu Jian introduced. GPHL’s role on this platform is that of a “full-chain enabler.”

To Forge Iron, One Must Be Strong Oneself

Guangdong’s breakthrough in innovative drugs and medical devices is changing from the lone courage of a few enterprises into a renewal of the industrial ecosystem.

Zhang Mingyuan said that the next 3 to 5 years will be a critical window period for traditional pharmaceutical companies to transform toward innovation-driven development, and also a strategic opportunity period for Guangdong’s innovative drugs and medical devices to move from “cluster emergence” to “global participation.” He said frankly that original innovation, patient capital, and global clinical and commercialization talent are still Guangdong’s shortcomings.

At present, these shortcomings are being filled. At the funding level, GPHL announced it would invest 50 billion yuan in innovation transformation, of which 20 billion yuan would be used for innovative drug R&D. At the R&D level, Yipinhong has more than 10 global innovative drugs under research, covering fields such as gout, diabetes, obesity, and autoimmune diseases, and has laid out cutting-edge technology platforms such as PROTAC and AI pharmaceuticals.

The path to going global has become more diversified. Yipinhong adopts a dual-track model of “independent regional markets + participation in global supply,” and has locked in in advance 100% complete market rights for AR882 in Greater China (including Hong Kong, Macao, and Taiwan). Akeso Biopharma licensed the global rights to its independently developed CTLA-4 monoclonal antibody to Merck in 2015; licensed part of the overseas rights to ivonescimab to Summit in 2022; and in 2025, penpulimab was approved by the U.S. FDA for marketing, becoming the first innovative biologic independently led by a Chinese company throughout the entire process and approved by the FDA.

“For Guangdong pharmaceutical companies to globalize, they must first adhere to taking clinical value as the core, and not ‘go global for the sake of going global,’” said Zhang Mingyuan. “To forge iron, one must be strong oneself; we must ensure our product quality is excellent.”

On the new track of AI pharmaceuticals, Guangdong is also accelerating its layout. XtalPi is an AI pharmaceutical company that grew up from the Shenzhen-Hong Kong Innovation and Technology Cooperation Zone. Multiple projects it has participated in incubating or empowering have entered clinical stages: the pan-TEAD inhibitor SIGX2649 discovered in cooperation with Signet Therapeutics obtained an FDA IND approval in advance; and RTX-117, the first domestic “AI+RNA” small-molecule drug developed in cooperation with incubated company Ribo Therapeutics, has also completed first patient dosing.

Liu Jian said that AI pharmaceuticals is a development direction for the biopharmaceutical industry. At present, the gap between China and foreign countries is relatively small, and with domestic accumulation in AI talent and computing power foundations, this field is “developing very rapidly, and the probability of catching up with and surpassing the world’s first-class level is very high.”

Today, “Made in Guangdong” appears more and more on the instructions of innovative drugs. Guangdong pharmaceutical companies are proving with one product after another: innovative drugs grown on this land have the confidence to stand on the world stage.

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Source: Yangcheng Evening News
Reprint source: Guangdong Medical Products Administration