When will the latest and best innovative drugs from around the world come to China? Multinational pharmaceutical company Sanofi is demonstrating through practical actions that China can be the "first stop" for new drugs worldwide.

From December 2025 to January 2026, within just a few weeks, Sanofi has received two consecutive approvals for cardiovascular drugs in China. They are respectively the world's first new drug Afketotai tablets (trade name: Xingshuping) ??? It has the best potential in its class and the world's first Plezilan Sodium Injection (trade name: Ruidapu) ??? Filling a treatment gap in an important disease field.

In fact, the consecutive approval of Sanofi's "cardiovascular twin stars" is also the result of deep integration with Chinese partners and a clear proof of Sanofi's innovative BD (business development) model.

2025 can be regarded as the first year of China's innovative drug BD trading explosion. According to data from the Medical Magic Cube, the total transaction amount of China's innovative drug BD's overseas authorization in 2025 reached 135.655 billion US dollars, setting a new historical high.

While innovative drugs in China are borrowing ships to set sail, Sanofi China is taking a different approach. At the end of 2022, the headquarters authorized Sanofi China to introduce pipelines. Since then, based in China, Sanofi has taken the initiative to go deep into China's indigenous innovative drug ecology, explore the most potential drug molecules, and rely on its own strong development and commercialization strength to make drugs benefit Chinese patients as early as possible.

Since the end of 2024, Sanofi has obtained the development and commercialization rights of Afketotai tablets and Prezilan sodium injection in the Greater China region through BD cooperation with Jixing Pharmaceutical and Weiyazhen. Two new drugs were approved one after another within less than a year.

This fully confirms China's support for 'global new' innovative drugs, meeting clinical urgent needs at the 'Chinese speed', "said Shi Wang, President of Sanofi Greater China.

In 2026, Sanofi has been in China for 44 years and continues to forge ahead, racing for the next cycle and achieving the "Chinese acceleration" of new drugs through innovative BD models. And consistently, it is Sanofi's long-term commitment to the Chinese market.

Bring better and newer drugs to China as soon as possible

Cardiovascular disease has become the "number one killer" threatening the health of Chinese residents. Sanofi, with rich experience in the cardiovascular field, has once again brought two breakthrough solutions to Chinese patients.

Firstly, Afketai tablets have pushed the treatment of hypertrophic cardiomyopathy to a new level.

Afkaitai tablets have been approved for the treatment of adult patients with obstructive hypertrophic cardiomyopathy classified as II-III by the New York Heart Association to improve exercise capacity and symptoms.

Hypertrophic cardiomyopathy is the most common genetic heart disease, which can lead to fatal risks such as sudden death, heart failure, and thromboembolism. It is one of the most common causes of sudden cardiac death in adolescents and athletes. About two-thirds of them belong to obstructive hypertrophic cardiomyopathy with poorer prognosis.

Previously, in the treatment of obstructive hypertrophic cardiomyopathy, traditional drugs could only alleviate some symptoms and could not intervene in the etiology of the disease or delay its progression. However, invasive treatment requires high professional skills and experience, has poor accessibility, and generally suffers from surgical complications. There is a high risk of re intervention, and the acceptance rate among patients is generally low.

And Afketai films directly capture the essence of diseases:

The core of treating obstructive hypertrophic cardiomyopathy is to reduce the obstructive pressure gradient, therefore, rapidly reducing the left ventricular outflow tract pressure gradient (LVOT-G) and improving symptoms is the primary task, "Professor Ma Changsheng introduced. He is the Chairman of the Cardiovascular Disease Branch of the Chinese Medical Association, the Director of the Cardiology Center at Beijing Anzhen Hospital affiliated with Capital Medical University, and the key global Phase 3 clinical researcher of Afketotai tablets in China.

Clinical research data shows that using Afketai tablets for 2 weeks can reduce LVOT-G by 20mmHg, 48mmHg at 12 weeks, and 50mmHg at 24 weeks. It can quickly improve symptoms and enhance cardiac function, and has good safety. The incidence of adverse events is comparable to placebo.

At present, Afketai tablets have been recommended by multiple domestic and international guidelines, including the "Chinese Comprehensive Management Guidelines for Cardiomyopathy 2025".

In recent years, with the National Medical Products Administration vigorously promoting the comprehensive acceleration of innovative drug review and approval, the speed of "global new" innovative drugs being launched in China has significantly accelerated. In December 2025, Afcetec tablets achieved global approval in China, a milestone that is the result of the Chinese government's support for innovation and comprehensive regulatory reform. It witnesses China's transformation from following and leading in the approval of innovative drugs, creating a new pattern of "global first release" from new indications to new molecular drugs. It also demonstrates the urgent need for innovation and clinical needs to quickly meet the rapid control needs of Chinese obstructive HCM patients.

Secondly, Plezilan Sodium Injection fills the treatment gap in important disease areas.

On the basis of dietary control, sodium prednisolone injection can be used to reduce triglyceride levels in adult patients with familial chylomicron syndrome (FCS).

Triglycerides are a type of blood lipid, and if their level in the human blood is ? 5.6mmol/L, it is severe hypertriglyceridemia. This disease affects the health of nearly 20 million people in China, and its serious complication is acute pancreatitis. Patients face the risk of shock, respiratory failure, multiple organ failure, and even death. The mortality rate associated with severe acute pancreatitis can reach 30%.

If the patient's triglyceride level is ? 10mmol/L and one of the following four conditions is present, FCS can be diagnosed: positive FCS related gene testing, family history of hypertriglyceridemic pancreatitis, history of adolescent pancreatitis or adult hypertriglyceridemic pancreatitis, and hospitalization history of unexplained recurrent abdominal pain.

However, such a disease that brings severe burden and "secondary disasters" has long lacked effective drugs in China. Ma Changsheng pointed out that "conventional treatment plans can reduce triglycerides by 25% -50% in people with hypertriglyceridemia, but are basically ineffective for FCS patients".

Plezilan Sodium Injection is a transformative therapeutic drug for triglyceride management. It is the world's first small interfering RNA drug that targets the inhibition of APOC3 mRNA, significantly reducing triglyceride levels and the risk of acute pancreatitis.

According to Professor Li Yong, Vice Chairman of the Chinese Cardiovascular Metabolism Alliance, Chief Physician of the Department of Internal Medicine (Cardiovascular Disease) at Huashan Hospital affiliated with Fudan University, and main researcher of the Phase 3 clinical trial of Plezilan Sodium in China, "Global Phase 3 clinical data shows that FCS patients observed a significant decrease in fasting triglyceride levels after using Plezilan Sodium Injection for one month. Fasting triglyceride levels decreased by 80% compared to baseline after 10 months of treatment, and the risk of acute pancreatitis decreased by 80% compared to placebo after 12 months

Clinical trials have shown that there is no significant difference in overall risk of adverse events compared to the placebo group in terms of safety, and the incidence of serious adverse events and drug discontinuation is lower than that of the placebo group. At the same time, Plezilan Sodium Injection only needs to be administered four times a year, providing patients with convenient and highly dependent treatment options to the greatest extent possible.

As Shi Wang pointed out, "the approval of Plezilan Sodium Injection in China not only fills the unmet needs of patients in the FCS field, but also promotes a new era of triglyceride management in China.

In addition, in December 2025, the US Food and Drug Administration awarded the breakthrough therapy designation of Plezilan Sodium Injection for severe hypertriglyceridemia. In the future, there is hope to further expand the scope of treatment management and benefit more patients.

Innovative BD from China to China

Afketotai tablets and Plezilan sodium injection are both drugs jointly developed by Sanofi China BD. From acquisition to approval, it took less than a year:

In December 2024, Sanofi acquired the exclusive rights of Jixing Pharmaceutical to develop and commercialize Afketotai tablets in Greater China for the treatment of obstructive and non obstructive HCM patients. Previously, Jixing Pharmaceutical obtained the development and commercialization rights of Afketai tablets in Greater China from Cytokinetics based on Cytokinetics' global registration plan.

In August 2025, Sanofi announced the signing of an asset purchase agreement with Visirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals, to acquire the rights to develop and commercialize the investigational drug, Prezilan Sodium Injection, in Greater China. Sanofi has made a prepayment of $130 million to Viyazhen and will pay up to $265 million in additional milestone payments.

When the above cooperation was reached, both drugs had obtained breakthrough therapy recognition from the US Food and Drug Administration and the Drug Evaluation Center of the China National Medical Products Administration, and had already submitted new drug registration applications.

In the later stage, Sanofi made bold moves and quickly made a decisive decision, demonstrating astonishing courage and sharpness, and seizing the opportunity in the next cycle of disease diagnosis and treatment.

Shi Wang emphasized, "This is different from the approach of some multinational pharmaceutical companies relying on a single global pipeline, but rather maximizing innovation efficiency by integrating local experience with the global advantages of multinational companies

Such strong operational capability and strategic vision are related to Sanofi China's acquisition of BD autonomy.

Shi Wang introduced that the license in rights for pipeline purchases have always been under the jurisdiction of Sanofi headquarters, and no market in any country has ever had the right to do so. China is the first exception. At the end of 2022, Sanofi China obtained the authority to independently make decisions and purchase research and development pipelines.

Higher authority means that Sanofi has full trust and confidence in the Chinese market.

According to Shi Wang, this breakthrough stems from three major consensuses between the company headquarters and the Chinese team: firstly, the Chinese market has a sufficiently large volume; 2? The disease spectrum in China is unique; 3? The local innovation ability has become globally competitive.

After several years of exploration, Sanofi China has found a clear path for BD screening:

Firstly, priority should be given to selecting categories with significant clinical value and the ability to change treatment patterns, especially first in class and best in class drugs; Secondly, it values collaborative innovation capabilities and tends to favor local enterprises with deep research and development accumulation in specific fields, capable of providing high-quality clinical data or technical support; The third is to focus on national key diseases and target unmet clinical needs.

The introduction of Afkaitai tablets and Plezilan sodium injection is Sanofi's two major victories in the cardiovascular pipeline.

We hope to achieve an efficiency of 1+1>2 through the combination of global experience from multinational corporations and clinical insights from local enterprises, "said Shi Wang." Firstly, we consider the scientific innovation of the asset, while also confirming whether it meets the medical needs of Chinese patients. Of course, if the opportunity is suitable, we will also consider the possibility of global transactions to give Chinese innovation the chance to go global

In the future, we will continue to promote the commercialization of innovative drugs and amplify the value of classic products, which is Sanofi's commitment in the field of chronic diseases. Meeting the long-term management needs of billions of chronic disease patients and finding a new balance between 'keeping the right track' and 'innovating', "Shi Wang emphasized.

Building a Healthy China with Longtermism

The change in BD permissions reflects Sanofi's long-term judgment and strategic confidence in the Chinese market.

According to Shi Wang, starting from 2024, the Chinese market has become one of Sanofi's four major global markets, parallel to the US market, core market, and international market, and has received unprecedented authorization and resource allocation. Sanofi firmly believes in and bets on China, and provides real investment and action support.

The two drugs approved this time are focused on the cardiovascular field. Why is Sanofi currently weighing heavily on China's cardiovascular and chronic disease track?

Shi Wang summarized the answer into two key words: space and time.

Firstly, the spatial dimension. China is rapidly entering a deeply aging society, with a population of over 100 million patients suffering from cardiovascular diseases. The "Healthy China Action Plan (2023-2030)" explicitly lists cardiovascular and cerebrovascular prevention and treatment as one of its core goals. At the same time, the new policy of diversified payment and accessibility for innovative drugs is also opening up new incremental space.

Shi Wang believes that this "one body, two sides" environment indicates that the Chinese market is rapidly maturing. The competition between multinational pharmaceutical companies and Chinese innovation forces is not a zero sum game of one or the other, but rather an amplification of the entire market value space.

Secondly, the time dimension. In Shi Wang's view, there are three major advantages of China's innovative drug management line that cannot be ignored:

One is the advantage of faster speed compared to other markets; Secondly, the R&D cost advantage compared to other major markets; The third advantage is the global leading digital innovation. According to analysis by some investment banks, it is highly likely that over 30% of the world's early innovative drug regulatory lines will come from China within the next five years.

Based on the above judgment, Sanofi continues to promote its long-term strategy in China and continues to advance its layout: on the one hand, it continuously adds local investment in research and development and production; On the other hand, actively participating in medical insurance negotiations to enhance the accessibility of innovative drugs.

The cardiovascular field is one of the core areas for the prevention and treatment of the four major chronic diseases in 'Healthy China', and it is also a key business for Sanofi to achieve its goal of becoming a leading multinational pharmaceutical enterprise in China, "said Shi Wang." In the future, Sanofi will continue to focus on the unmet needs of patients in the cardiovascular field, promote the landing of more innovative products under diversified models, safeguard the cardiovascular health of Chinese people, and jointly build a healthy China 2030

As a leader in the cardiovascular field, Sanofi is continuously consolidating its moat in the field and striving to bring the best scientific innovations to patients at the fastest speed possible. And Sanofi's commitment to Chinese patients goes far beyond that.

From 2020 to the end of 2025, Sanofi has accumulated 34 approved innovative drugs, vaccines, and new indications in China, exceeding the established goal of introducing 25 innovative products in China between 2020 and 2025. By 2025 alone, Sanofi will have seven innovative drugs and new indications approved in China.

In 2025, Sanofi has 26 clinical trial applications approved, which has increased innovation in the fields of immunity, nerves, tumors, transplantation, diabetes and cardiovascular. This also includes three innovative vaccines: the 21 valent pneumonia vaccine, the quadrivalent meningitis vaccine, and the children's six valent vaccine.

With the support of Chinese policies, Sanofi has accelerated the introduction of 21 innovative products and achieved global synchronized registration and submission of these products for listing in China in the three years from 2023 to 2025.

The firm bet on China's strategic layout has yielded tangible results, which is enough to prove the depth and breadth of Sanofi's "in China, for China" strategy. Sanofi, which is working together with China, will continue to take practical actions to support the "Healthy China" campaign. For Sanofi, long termism is not just a slogan, but a practical winning factor.