Sanofi Cardiovascular Twin Stars Approved: Innovative Business Development Accelerates Global New Drug Launch

The latest and best innovative medicines worldwide—when will they arrive in China? Multinational pharmaceutical company Sanofi is demonstrating through concrete actions that China can be the “first stop” for new drugs globally.

From December 2025 to January 2026, within just a few weeks, Sanofi received approvals for two cardiovascular drugs in China. These are the first-in-class new drug Avkaitai Tablets (brand name: Xing Shu Ping), with top potential among peers, and the first-in-class Pulesiran Sodium Injection (brand name: Rida Pu), filling an important treatment gap in a key disease area.

In fact, the approval of Sanofi’s “cardiovascular twin stars” is also the result of deep integration with Chinese partners and a testament to Sanofi’s innovative business development (BD) model.

2025 is considered the inaugural year of a burst in China’s innovative drug BD transactions. Data from Pharma Cube shows that the total transaction amount for China’s outbound licensing of innovative drugs in 2025 will reach $135.655 billion, setting a new record.

While many Chinese innovative drugs are going abroad, Sanofi China has taken a different approach. At the end of 2022, the headquarters authorized Sanofi China to introduce pipeline rights. Since then, Sanofi has focused on China, actively delving into the local innovative drug ecosystem, discovering the most promising drug molecules, and leveraging its strong development and commercialization capabilities to benefit Chinese patients as early as possible.

Since late 2024, through BD collaborations with Jixing Pharmaceuticals and Viasirna Therapeutics, Sanofi has obtained development and commercialization rights for Avkaitai Tablets and Pulesiran Sodium Injection in Greater China. Both drugs have been approved within less than a year afterward.

“This fully demonstrates China’s support for ‘global new’ innovative drugs, meeting urgent clinical needs with ‘Chinese speed,’” said Shiwang, President of Sanofi Greater China.

By 2026, Sanofi has been in China for 44 years and continues to forge ahead, racing to the next cycle with an innovative BD model to accelerate the development of new drugs in China. What remains consistent is Sanofi’s long-term commitment to the Chinese market.

Bringing better and newer medicines to China as early as possible

Cardiovascular disease has become the number one killer threatening the health of Chinese residents. With a rich foundation in cardiovascular medicine, Sanofi is once again bringing two breakthrough solutions to Chinese patients.

First, Avkaitai Tablets elevate the treatment of hypertrophic cardiomyopathy to a new level.

Avkaitai Tablets have been approved for treating adult patients with NYHA class II-III obstructive hypertrophic cardiomyopathy, to improve exercise capacity and symptoms.

Hypertrophic cardiomyopathy is the most common inherited heart disease, which can lead to sudden death, heart failure, thrombosis, and embolism—one of the most common causes of sudden cardiac death among adolescents and athletes. About two-thirds of cases are obstructive hypertrophic cardiomyopathy, which has a worse prognosis.

Previously, traditional medications could only alleviate some symptoms of obstructive hypertrophic cardiomyopathy, without addressing the disease’s cause or slowing its progression. Invasive treatments require high technical expertise and experience, have limited accessibility, and carry risks of surgical complications and re-interventions, leading to low patient acceptance.

Avkaitai Tablets directly target the disease’s essence:

“Treating obstructive hypertrophic cardiomyopathy primarily involves reducing the outflow tract pressure gradient, so rapidly lowering the left ventricular outflow tract pressure (LVOT-G) and improving symptoms are the top priorities,” explained Professor Changsheng Ma. He is the Chair of the Chinese Society of Cardiology, Director of the Cardiology Center at Beijing Anzhen Hospital affiliated with Capital Medical University, and the principal investigator of the key global Phase 3 clinical trial for Avkaitai Tablets in China.

Clinical data show that using Avkaitai Tablets for 2 weeks can reduce LVOT-G by 20mmHg, 12 weeks by 48mmHg, and 24 weeks by 50mmHg, quickly improving symptoms and cardiac function with good safety, and adverse event rates comparable to placebo.

Currently, Avkaitai Tablets are recommended in multiple domestic and international guidelines, including the “Chinese Cardiomyopathy Comprehensive Management Guidelines 2025.”

In recent years, with the vigorous promotion of innovation drug review and approval by the National Medical Products Administration (NMPA), the speed of bringing “global new” innovative drugs to China has greatly accelerated. In December 2025, Avkaitai Tablets achieved global first approval in China. This milestone reflects the Chinese government’s support for innovation, comprehensive regulatory reforms, and marks China’s transition from following and paralleling to leading in drug approvals. It also opens a new pattern of “global first-in-class” drugs expanding from new indications to entirely new molecules, demonstrating the urgent need to quickly meet the clinical demands of Chinese patients with obstructive HCM.

Second, Pulesiran Sodium Injection fills a critical treatment gap in a major disease area.

Based on dietary control, Pulesiran Sodium Injection can be used to lower triglyceride levels in adults with familial chylomicronemia syndrome (FCS).

Triglycerides are a type of blood lipid. When levels in the blood are ≥5.6mmol/L, it is considered severe hypertriglyceridemia, affecting nearly 20 million people in China. Its serious complication is acute pancreatitis, which carries risks of shock, respiratory failure, multi-organ failure, and death, with a mortality rate of up to 30% during severe episodes.

If triglyceride levels are ≥10mmol/L and one of the following four conditions is met, FCS can be diagnosed: positive FCS-related gene testing, family history of hypertriglyceridemic pancreatitis, history of juvenile or adult hypertriglyceridemic pancreatitis, or recurrent unexplained abdominal pain requiring hospitalization.

However, such a disease that imposes a heavy burden and secondary disasters has long lacked effective drugs in China. Ma Changsheng pointed out, “Conventional treatments reduce triglycerides by 25%-50% in hypertriglyceridemia patients, but are essentially ineffective for FCS patients.”

Pulesiran Sodium Injection is a revolutionary treatment for triglyceride management. It is the world’s first small interfering RNA (siRNA) targeting APOC3 mRNA, capable of significantly lowering triglyceride levels and reducing the risk of acute pancreatitis.

Professor Li Yong, Vice Chairman of the Chinese Cardiovascular Metabolism Alliance, Chief Physician at Huashan Hospital affiliated with Fudan University, and the main investigator of the Phase 3 clinical trial of Pulesiran in China, explained: “Global Phase 3 clinical data show that FCS patients experience a significant reduction in fasting triglycerides within 1 month of using Pulesiran Sodium Injection, with an 80% reduction from baseline after 10 months of treatment, and an 80% reduction in the risk of acute pancreatitis after 12 months compared to placebo.”

Clinical trials indicate that in terms of safety, the overall risk of adverse events is not significantly different from placebo, and the incidence of serious adverse events and discontinuation rates are lower than placebo. Additionally, Pulesiran Sodium Injection requires only four doses per year, providing patients with a convenient and highly adherent treatment option.

As Shiwang pointed out, “The approval of Pulesiran Sodium Injection in China not only fills an unmet need for FCS patients but also propels triglyceride management into a new era in China.”

Furthermore, in December 2025, the U.S. FDA granted Breakthrough Therapy designation to Pulesiran Sodium Injection for severe hypertriglyceridemia, with further expansion of its therapeutic scope anticipated to benefit more patients.

“From China, to China” — Innovative BD

Avkaitai Tablets and Pulesiran Sodium Injection are both drugs developed through Sanofi China’s BD collaborations. The entire process from acquisition to approval took less than a year:

In December 2024, Sanofi acquired exclusive rights from Jixing Pharmaceuticals for the development and commercialization of Avkaitai Tablets in Greater China, for treating obstructive and non-obstructive HCM. Previously, Jixing had obtained development and commercialization rights in Greater China from Cytokinetics based on its global registration plan.

In August 2025, Sanofi announced a deal with Viasirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals, to acquire rights to develop and commercialize the investigational drug Pulesiran in Greater China. Sanofi paid $130 million upfront and agreed to pay up to $265 million in additional milestone payments.

Both drugs had already received Breakthrough Therapy designation from the U.S. FDA and China’s NMPA’s Center for Drug Evaluation, and had submitted new drug registration applications.

Sanofi’s bold and swift actions in later stages demonstrate remarkable decisiveness and agility, seizing opportunities in the next disease treatment cycle.

Shiwang emphasized, “This is different from some multinational companies relying on a single global pipeline; instead, it’s about integrating local experience with the global advantages of multinational corporations to maximize innovation efficiency.”

Such strong operational capability and strategic vision are related to the autonomous BD rights granted to Sanofi China.

Shiwang explained that, historically, pipeline licensing (license-in) rights have always belonged to Sanofi headquarters, and no other country’s market has had such authority. China is the first exception. At the end of 2022, Sanofi China gained the authority to independently decide and purchase R&D pipelines.

This higher level of authority reflects Sanofi’s full trust and confidence in the Chinese market.

According to Shiwang, this breakthrough stems from three major consensus points between the company headquarters and the Chinese team: First, the Chinese market is large enough; second, China’s disease spectrum is unique; third, local innovation capabilities have reached a globally competitive level.

After years of exploration, Sanofi China has identified a clear pathway for BD screening:

First, prioritize categories with significant clinical value that can change treatment paradigms, especially first-in-class and best-in-class drugs; second, value synergistic innovation capabilities, favoring domestic companies with deep R&D experience and high-quality clinical data or technical support; third, focus on key national diseases and unmet clinical needs.

The introduction of Avkaitai Tablets and Pulesiran Sodium Injection marks two major successes in Sanofi’s cardiovascular pipeline.

“We aim to achieve 1+1>2 efficiency through ‘global experience of multinational companies + local clinical insights,’” Shiwang said. “First, consider the scientific innovation of assets, and whether they meet Chinese patients’ medical needs. Of course, the timing must be right, and we will also explore global transactions to give Chinese innovation a chance to go global.”

“Going forward, we will continue to promote the commercialization of innovative drugs and amplify the value of flagship products—Sanofi’s commitment in the chronic disease field. We aim to meet the long-term management needs of hundreds of millions of chronic disease patients, balancing ‘stability’ and ‘innovation,’” Shiwang emphasized.

Building a Healthy China with Long-term Vision

Changes in BD rights reflect Sanofi’s long-term judgment and strategic confidence in the Chinese market.

Shiwang explained that starting in 2024, China became one of Sanofi’s four major global markets, alongside the U.S., core markets, and international markets, receiving unprecedented authorization and resource support. Sanofi remains optimistic about China, investing and acting decisively.

The two approved drugs focus on cardiovascular areas. Why is Sanofi emphasizing China’s cardiovascular and chronic disease tracks now?

Shiwang attributes this to two keywords: space and time.

First, space. China is rapidly entering a deeply aging society, with over 100 million cardiovascular disease patients. The “Healthy China Action (2023–2030)” explicitly lists cardiovascular and cerebrovascular prevention and treatment as key goals. Meanwhile, innovative drug multi-payment and accessibility policies are opening new growth opportunities.

Shiwang believes this “dual-faceted” environment indicates China’s market is maturing quickly. Competition between multinational companies and Chinese innovators is not a zero-sum game but a broadening of market value.

Second, time. In Shiwang’s view, China’s innovative drug pipeline has three major advantages:

1. Faster development speed compared to other markets;
2. Lower R&D costs than other major markets;
3. Leading digital innovation globally. According to some investment bank analyses, within five years, over 30% of early-stage innovative drug pipelines are likely to originate from China.

Based on these judgments, Sanofi continues to pursue long-term strategies in China, with proactive deployment: increasing local investment in R&D and manufacturing, and actively participating in healthcare negotiations to improve access to innovative medicines.

“Cardiovascular is one of the four core areas of chronic disease prevention in ‘Healthy China,’ and a key business for Sanofi to realize its goal of becoming China’s leading multinational pharmaceutical company,” Shiwang said. “In the future, Sanofi will continue to focus on unmet needs of cardiovascular patients, promote more innovative products through diverse models, protect Chinese cardiovascular health, and build a healthy China 2030.”

As a leader in cardiovascular medicine, Sanofi is continuously strengthening its moat in this field and striving to deliver the best scientific innovations to patients at the fastest pace. But its commitment to Chinese patients goes far beyond that.

From 2020 to the end of 2025, Sanofi has cumulatively approved 34 innovative medicines, vaccines, and new indications in China, exceeding the target of 25 innovative products introduced in China from 2020 to 2025. In 2025 alone, Sanofi had 7 innovative drugs and new indications approved in China.

In 2025, Sanofi had 26 clinical trial applications approved, increasing innovation efforts in immunology, neurology, oncology, transplantation, diabetes, and cardiovascular areas. This includes three innovative vaccines: 21-valent pneumonia vaccine, quadrivalent meningococcal vaccine, and pediatric hexavalent vaccine.

Supported by Chinese policies, between 2023 and 2025, Sanofi accelerated the introduction of 21 innovative products and achieved global simultaneous registration submissions for these products in China.

Its strategic focus on China has borne tangible results, demonstrating Sanofi’s deep and broad commitment of “in China, for China.” Sanofi, working hand in hand with China, will continue to take concrete actions to support the “Healthy China” initiative. For Sanofi, long-termism is not just a slogan but a key element of victory.