From Plavix Price Cuts to Praluent Exit: How Sanofi and Other Multinationals Are Pivoting in China

Author: Joanna

Recently, Sanofi issued formal notifications to numerous hospitals across China, announcing that its novel lipid-lowering drug, Praluent (alirocumab injection), will cease promotional activities in the Chinese market and gradually withdraw from it.

Meanwhile, Sanofi’s performance in the Chinese market during the first half of the year was also less than satisfactory.

Sanofi’s financial report for the first half of 2025 shows that the company achieved total revenue of €19.889 billion, a year-on-year increase of 9.9%; R&D investment during the same period reached €3.717 billion (approximately $4.074 billion), accounting for 18.7% of total revenue. However, in terms of regional revenue distribution, Sanofi’s revenue from the U.S. market in the first half of 2025 reached €9.535 billion (approximately $10.451 billion), up 16.4% year on year; revenue from the European market was €4.144 billion (approximately $4.542 billion), up 1.8% year on year; while revenue from the Chinese market was €1.388 billion (approximately $1.521 billion), with a slight year-on-year increase of only 0.1%. Compared with other major markets, growth momentum in the Chinese market has slowed significantly, showing a trend of decelerating growth.

The delisting of Plavix is not an isolated case. In recent years, numerous multinational pharmaceutical companies, including Bayer and Merck & Co., have been adjusting their pipelines in China, downsizing teams, or discontinuing certain business operations.

Driven by multiple factors, including tightening global drug pricing policies and the rapid penetration of biosimilars, the traditional business model reliant on “high prices + patents” is facing unprecedented challenges. In China, as the national medical insurance negotiation mechanism matures, the volume-based procurement system is implemented, and local pharmaceutical companies rise in innovative drug R&D, the market influence of multinational corporations is being reshaped.

Despite numerous challenges, the Chinese pharmaceutical market still holds immense potential. Multinational pharmaceutical companies are also undergoing a transformation from “exporters” to “co-creators.”

01.

Market Shakeout: Polida Exits China

It is reported that Praluent, the product that has stirred up significant controversy, was approved by China’s National Medical Products Administration (NMPA) in December 2019 for the prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease, as well as for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial forms) and mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) levels. Moreover, China is the first country worldwide to simultaneously approve both major indications for Praluent, with its market launch occurring two months ahead of schedule. Thus, Praluent can be said to have rapidly entered the Chinese market “on the fast track of accelerated approval.”

To reduce the prices of high-cost innovative drugs and improve their accessibility, the Chinese government began implementing the National Drug Price Negotiation (NDPN) policy in 2017. Through a national collective bargaining mechanism, this policy aims to lower the prices of innovative drugs, with inclusion in the National Reimbursement Drug List (NRDL) contingent upon successful negotiation. In 2021, under the influence of the NDPN policy, all PCSK9 inhibitors available on the Chinese market at that time—including Bolida—were included in the NRDL.

As one of the first PCSK9 monoclonal antibodies to enter the Chinese market, the launch of Bolida marks a formal transition in China’s lipid-lowering therapy for cardiovascular diseases from traditional statins to an era of “precise target” treatment. From its accelerated approval and market launch to its successful inclusion in the National Reimbursement Drug List, every step has aligned precisely with policy developments. Consequently, high expectations are placed on Bolida, which is poised to achieve substantial volume growth in the Chinese market.

In fact, there were early signs of Plavix’s market withdrawal. In December 2024, internal reports from Sanofi indicated that its Cardiovascular and Diabetes business line, under the General Medicines division, had initiated structural adjustments and layoffs, with the cardiovascular department ceasing promotion of Plavix and Praluent. The last working day for affected employees was scheduled for January 31, 2025. Starting in January 2025, patients and their families from various regions, including Zhejiang, Tianjin, Shandong, and Hubei, successively reported difficulties in obtaining prescriptions for Plavix at local hospitals.

Withdrawn from the market unceremoniously, without any clear safety warnings and before completing its full lifecycle, this decision has inevitably raised numerous questions about the underlying business judgment.

According to the notification letter issued by Sanofi, there are two main reasons for Praluent’s withdrawal from the Chinese market: first, challenges posed by global raw material supply shortages have extended to the Chinese market; second, more domestically produced PCSK9 inhibitors were included in the cholesterol management reimbursement treatment plans under the 2025 National Reimbursement Drug List of China, making the competitive landscape more diversified.

It is evident that the key reason for Sanofi’s decision to halt the supply of Plavix in China lies in changes to the market environment. What truly eroded its strategic position was the rapid rise of alternative products and the increasingly prominent cost-effectiveness disadvantage of Plavix amid intense competition.

In August 2023, Inclisiran (brand name: Leqvio), marketed by Novartis, was approved for launch in China. As an adjunct to diet, it is indicated for the treatment of adults with primary hypercholesterolemia (including heterozygous familial and non-familial) or mixed dyslipidemia.

It is reported that Inclisiran is a long-acting lipid-lowering drug based on siRNA technology, requiring administration only twice a year. This regimen offers higher patient adherence and makes it particularly distinctive among PCSK9 inhibitors. In contrast, Bolida (Alirocumab) requires injection every two weeks. Although its price dropped significantly from RMB 1,982 per vial to RMB 306 per vial following national medical insurance negotiations, the high frequency of injections still causes inconvenience for many patients.

In the U.S. market, inclisiran is priced at $3,250 per injection, with an annual treatment cost of approximately $6,500 (equivalent to about RMB 45,000). In the Chinese market, its launch price was RMB 9,988 per injection, and demand initially outstripped supply.

According to Novartis’s 2024 annual financial report, Inclisiran achieved global sales of $754 million for the full year, representing a 114% year-on-year increase. It has become the second best-selling product in Novartis’s cardiovascular portfolio, demonstrating strong growth momentum.

Meanwhile, the R&D and commercialization of PCSK9 inhibitors by multiple domestic pharmaceutical companies have also entered the "payoff period."

Taking Junshi Biosciences as an example, the marketing authorization application for its independently developed ongericimab injection (recombinant humanized anti-PCSK9 monoclonal antibody injection; brand name: Junshida®) was approved by the NMPA in October 2024 for the treatment of adult patients with primary (non-familial) hypercholesterolemia and mixed dyslipidemia. In May 2025, two additional indications for this product were also approved: first, for adult patients with heterozygous familial hypercholesterolemia (HeFH); and second, for the treatment of non-familial hypercholesterolemia and mixed dyslipidemia in adult patients who are intolerant to or have contraindications for statins, either as monotherapy or in combination with ezetimibe.

Furthermore, Hengrui Medicine’s rucalcimab has become the only ultra-long-acting PCSK9-targeting monoclonal antibody approved globally, with a 450 mg dose enabling administration once every 12 weeks, significantly improving patient adherence. Innovent Biologics’ tolecimab was successfully included in the National Reimbursement Drug List in December 2024, becoming the first domestically developed, original PCSK9 inhibitor covered by national insurance in China, where it competes directly with Amgen’s evolocumab and Sanofi’s alirocumab in the reimbursed market.

Notably, domestic brands not only hold a clear price advantage but also continue to innovate in terms of ease of use. For instance, the adoption of an advanced pressure-activated, pre-filled auto-injector pen design with hidden thin-wall needles can reduce puncture force by 70%, effectively alleviating injection pain, decreasing the rate of bleeding at the injection site, and enhancing patient experience.

02.

Strategic Transformation: Multinational Pharma Companies Accelerate “Decluttering”

This is not Sanofi’s first setback in China’s cardiovascular market.

Twenty years ago, Sanofi sparked a “prescription revolution” in China with its antiplatelet drug Plavix (clopidogrel bisulfate tablets). Leveraging early market positioning and exclusive patent protection, Plavix long dominated the cardiovascular therapy market in China, with global annual sales at their peak exceeding $10 billion.

With the expiration of the original patent in 2012, a large number of generic drugs rapidly flooded the market. Sanofi did not proactively adjust its prices but instead maintained its existing high-price strategy. This approach did not shake its dominant position in the Chinese market in the short term—data from 2018 showed that in the clopidogrel market across key provincial and municipal public hospitals, Sanofi, Salubris, and Lepu Medical formed a “tripartite balance,” with Sanofi still holding nearly 60% of the market share.

However, the policy shift immediately triggered a dramatic transformation in the market landscape. The “4+7” volume-based procurement (VBP) policy, aimed at promoting the substitution of generic drugs for originator drugs and driving down the prices of originator drugs, began to expand nationwide. Clopidogrel bisulfate was included among the first 25 drug categories subject to VBP.

In the first round of the “4+7” volume-based procurement, Sanofi was “outperformed” by Salubris and failed to win the bid, thereby losing its market in public hospitals across 11 pilot cities, including Beijing, Shanghai, and Guangzhou, leading to a rapid collapse of its market share.

In a bid to regain lost market share, Sanofi chose to make a “last stand” in the September 2019 national volume-based procurement (VBP) tender for expanded drug coverage, winning the bid at a price of RMB 2.54 per tablet—approximately 20% lower than its initial winning bid. This aggressive pricing strategy came as a major surprise to the market.

However, the “price-for-volume” strategy failed to reverse the downward trend. Sanofi’s sales in the Chinese market declined by 21% year-on-year in the fourth quarter of 2019, significantly impacting its global profits. During the subsequent earnings conference call, the head of Sanofi’s China and Emerging Markets business stated that Plavix sales in the Chinese market were expected to decline by approximately 50% further in 2020.

The decline in sales has not only sounded an alarm for Sanofi regarding the lifecycle management of “off-patent originator drugs,” but also heralds a profound shift in the role of multinational pharmaceutical companies in the Chinese market—transitioning from “product monopolists” previously reliant on patent protection to “quasi-public health service providers” facing policy constraints and price pressures.

Compared with the market collapse of Plavix, Plavida’s “voluntary supply suspension” carries greater strategic significance. It signals that foreign pharmaceutical companies are accelerating the “decluttering” of their local business structures—products lacking localized production capabilities and struggling to break through in price wars are rapidly losing priority in the Chinese market.

Sanofi is not an isolated case; in recent years, multinational pharmaceutical companies have frequently adjusted their strategies in China, with the trend of “structural contraction” in the Chinese market becoming increasingly pronounced.

In November 2024, Bayer’s collaboration in China’s diabetes market encountered an unexpected setback. Hua Medicine announced that it had formally issued a written notice to Bayer, reclaiming the commercialization rights for its self-developed diabetes drug, “Hua Tang Ning,” in the Chinese market effective January 1, 2025.

In February 2025, Merck & Co. announced that it would suspend the supply of its HPV vaccine products, Gardasil and Gardasil 9, to the Chinese market. This decision was subsequently extended until at least the end of 2025. Merck China stated that this move was primarily influenced by factors such as changes in the market environment, weak consumer demand, and channel inventory overstock. Nevertheless, the company remains confident in the long-term potential of the Chinese market.

Data also highlight the challenges posed by the Chinese market: in the second quarter of 2025, global sales of Gardasil fell by 55% year over year to approximately $1.1 billion; excluding sales in China, other regions worldwide posted a 7% increase, indicating that the decline in the Chinese market significantly dragged down its performance.

Not long ago, AstraZeneca’s 2025 semi-annual report also revealed adjustments to its cell therapy pipeline, with the formal termination of development for three products: NT-125, AZD5851, and AZD6422. Although these products demonstrated high levels of technical innovation, their discontinuation highlights numerous practical challenges in the clinical translation and industrialization of novel technologies. Key constraints include prolonged R&D cycles, complex manufacturing processes, difficulties in cost control, and low levels of standardization.

03.

From Global Pressure to China’s Opportunities: Accelerating Integration into the Local Innovation Ecosystem

It is worth noting that multinational pharmaceutical companies are facing global challenges.

Although the United States has long been one of the largest and most mature pharmaceutical markets globally, serving as a significant source of profits for multinational pharmaceutical companies, the “certainty dividend” of this market has been gradually diminishing in recent years. Numerous structural issues have become increasingly prominent, compelling companies to reevaluate their business models and capital allocation strategies in the U.S.

First, the continued tightening of drug price control policies is compressing corporate profit margins. In 2022, the United States formally passed the Inflation Reduction Act (IRA), which is poised for full implementation and poses unprecedented challenges to the pharmaceutical industry. Under this act, brand-name drugs will be subject to the Maximum Fair Price (MFP) negotiation mechanism, significantly shortening the profitability cycle of originator drugs. As stipulated, the Centers for Medicare & Medicaid Services (CMS) will prioritize for negotiation innovative drugs that lack generic alternatives and account for the highest share of Medicare spending. The first batch of 10 drugs selected for negotiation is expected in 2026, expanding to 20 by 2029, with further increases thereafter, covering both Part B and Part D drugs under the Medicare program.

Meanwhile, the rapid rise of biosimilars and local innovators is further squeezing the market share of multinational pharmaceutical companies. As the FDA continues to mature the approval pathway for biosimilars and lower market access barriers, an increasing number of cost-competitive biosimilars are quickly entering the market. For instance, companies such as Amgen, Coherus, and Samsung Bioepis have launched biosimilar versions in several high-margin therapeutic areas, posing substantial competitive pressure on originator drugs.

In this context, the Chinese market has undoubtedly become a critical battleground. The strategic adjustments made by multinational pharmaceutical companies in China are not only necessary measures to address challenges but also reflect their hope that the Chinese market will unleash new growth momentum.

Take Sanofi’s recent adjustment as an example. The Report on Cardiovascular Health and Diseases in China (2023) points out that the prevalence of cardiovascular disease (CVD) in China continues to rise, with an estimated 330 million current patients. Data from the China Health Statistics Yearbook (2022) shows that CVD ranks first among the causes of death for both urban and rural residents. Faced with such a vast market demand, Plavix’s “exit” does not mean that Sanofi has completely lost its opportunities; instead, it represents a strategic move to cut losses, making room for more forward-looking layouts.

Sanofi is rapidly strengthening its cardiovascular product pipeline by accelerating mergers and acquisitions.

On August 1, 2025, Sanofi announced the signing of an asset purchase agreement with Visirna Therapeutics, a subsidiary of Arrowhead. Under the agreement, Sanofi will acquire the rights to develop and commercialize the investigational drug ploxilan sodium injection in Greater China. Ploxilan sodium injection is Arrowhead’s first-in-class RNA interference (RNAi) therapeutic candidate designed to reduce the production of apolipoprotein C-III. In Greater China, it represents a potential treatment option for familial chylomicronemia syndrome and severe hypertriglyceridemia.

Furthermore, multinational pharmaceutical companies are increasingly prioritizing deep integration with China’s local R&D ecosystem, strengthening collaborative synergies to build innovation networks with enhanced localization advantages.

For example, in June 2025, Bayer and Tsinghua University announced the renewal of their scientific research cooperation agreement, extending the original 16-year partnership framework by an additional three years. This renewal aims to further promote the efficient translation of scientific achievements across the entire pharmaceutical R&D value chain. The renewed collaboration focuses on six key therapeutic areas, including oncology, cardiovascular diseases, nephrology, neurological disorders, rare diseases, and immunology.

Under the agreement, Bayer will continue to provide financial support for the joint research projects and resource backing for the cutting-edge research achievements of Tsinghua University scientists, further strengthening in-depth cooperation and talent exchange between the two parties in the fields of life sciences and pharmaceutical innovation.

In the new ecosystem, who will be the next Plavix? This may depend on how each multinational pharmaceutical company redefines “local value” and whether it truly listens to the voice of the Chinese market.