800 Million-Yuan Blockbuster Generic Launches: Domestic CDK4/6 Inhibitor Market Faces Major Shift

(Source: Pharmaguider)

On May 6, the NMPA approved two generic drugs in a single day—Abemaciclib Tablets (first generic) and Brivaracetam Injection (first-to-market). The former is a breast cancer targeted therapy with annual sales exceeding 800 million yuan, while the latter completes the formulation puzzle for anti-epileptic drugs. Amidst the increasingly fierce competition for first generics, this not only represents a speed contest between two companies but also reflects the strategic upgrade of locally produced generics in China, shifting from "following" to "seizing position" and expanding from single formulations to comprehensive coverage.

1. The First Generic Abemaciclib Lands – How to Divide the 800 Million RMB Pie?

Abemaciclib, an oral CDK4/6 inhibitor developed by Eli Lilly, has rapidly become a core drug for the treatment of HR+/HER2- advanced or metastatic breast cancer due to its proven efficacy and good tolerability since entering the Chinese market in December 2020. The market size continues to expand, making it a highly sought-after "hot commodity" among China-produced generic drug companies. The launch of its first generic version will completely disrupt the market dominance held by the original drug, initiating competition for shares in an 800-million-yuan market.

From the current market situation, the clinical demand and market potential of abemaciclib are particularly prominent. According to data from MagicEntropy Pharma, by 2025, the sales revenue of abemaciclib in China's all-terminal hospital market will exceed 800 million yuan, with a year-on-year increase of 11.80%, maintaining a steady growth trend. Behind this achievement lies a large patient base and a clear clinical positioning—HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for more than 70% of all breast cancer cases. CDK4/6 inhibitors have become the standard treatment regimen for advanced patients of this subtype, effectively blocking tumor cell cycle progression, inducing senescence and apoptosis of breast cancer cells, and significantly prolonging patients' progression-free survival.

During the period of original research monopoly, Eli Lilly, with its first-mover advantage, firmly occupied the entire share of the domestic abemaciclib market in China, keeping the medication costs for patients high and leaving ample room for the substitution of domestically produced generic drugs. This time, CorePharm was the first to receive approval for its Category 4 generic version of abemaciclib tablets, becoming the first domestic company to both launch a generic and pass the quality evaluation, cutting into this 800-million-yuan market. This marks the official start of domestic substitution. Notably, the field of generic drug applications is not dominated by CorePharm alone; Qilu Pharmaceutical is close behind, also having submitted an application for marketing authorization for its Category 4 generic version, which is currently in the review and approval stage. Given the small gap in production declaration times between the two companies, industry insiders expect Qilu Pharmaceutical to be approved within a few months, becoming the second company to pass the quality evaluation and forming an initial competitive landscape of "two giants vying for dominance."

Price Competition and Expectations of China-produced Alternatives Become the Core Focus of This First Generic Launch. Typically, after the first generic drug enters the market, its price is expected to drop to 50%-70% of the original research drug’s price. This pricing advantage will greatly improve drug accessibility, particularly for breast cancer patients who require long-term medication, significantly reducing their medication costs. Meanwhile, the launch of the first generic drug will also exert substantial pressure on the original drugmaker, Eli Lilly, during national healthcare negotiations — if Eli Lilly does not adjust its pricing strategy, its market share risks being quickly eroded by domestically produced generics; but if it proactively lowers prices, it will squeeze its own profit margins, creating a dilemma.

The broader impact is that the first generic version of Abemaciclib will trigger a chain reaction in the entire domestically produced CDK4/6 inhibitor market. Currently, in addition to Abemaciclib, the CDK4/6 inhibitor market in China includes Palbociclib and Ribociclib, among others. The competition for generic versions of Palbociclib has become intense. The rapid progress of the first generic Abemaciclib will further accelerate the pace of generic drug competition across the field, pushing other companies producing generics to expedite their application processes. This will drive down the overall price of CDK4/6 inhibitors, benefiting more patients.

However, it is important to clarify that the approval of the first generic is merely the starting point of market competition, not the endpoint. For CorePharm, securing a competitive edge in an 800-million-dollar market requires more than just the "first generic" label. Production capacity, channel coverage, and academic promotion capabilities will be the key factors determining subsequent market expansion. On the other hand, Qilu Pharmaceutical, a leading generic drug company in China's oncology sector, boasts a mature sales network and extensive experience in academic promotion. Even as the second company to gain approval, Qilu Pharmaceutical is well-positioned to quickly capture market share through its channel advantages, creating a strong rivalry with CorePharm. In the future, the competition between the two companies will shift from "approval speed" to "market operation capabilities," which will become the core competitiveness for Chinese generic drug manufacturers striving to dominate the market.

2. Brivaracetam "Oral + Injection" Dual Formulations – Moat or Standard Feature?

As Abemaciclib's first generic version lands, CorePharm's Brivaracetam Injection has been simultaneously approved, making it the first company in China to obtain approval for this formulation. Combined with the Brivaracetam Tablets that were first approved in 2024, CorePharm has now achieved a "oral + injectable" dual-formulation layout for Brivaracetam. This strategy not only demonstrates the company’s R&D and application capabilities but also sparked in-depth industry reflections on the "value of dual-formulation strategies": In an increasingly competitive generic drug market, is the dual-formulation approach a differentiated moat for companies, or will it become a standard feature in future market competition?

Overview of Brivaracetam: This drug, developed by UCB, belongs to a new generation of antiepileptic medications and is a second-generation synaptic vesicle protein 2A ligand. Structurally similar to levetiracetam, it features rapid onset and good tolerability, primarily used for treating focal seizures. In terms of market size, brivaracetam has shown impressive global performance, with UCB's global sales exceeding $700 million in 2024. Although the domestic market in China currently has a lower base, it is experiencing rapid growth. Data from MaxEntropy Healthcare shows that by 2025, hospital sales across all terminals for this drug will surpass 30 million yuan. With its increasing clinical adoption, the future market potential is promising.

Corey Pharmaceutical Maintains a Leading Position in the Localization of Brivaracetam in China: In 2024, its Brivaracetam Tablets were the first to be approved for marketing, becoming the exclusive domestic product and successfully included in the National Medical Insurance Catalog. With the support of medical insurance, it quickly achieved market penetration. The recent approval of Brivaracetam Injection further perfected the product form layout, forming a complete product portfolio of "oral + injection," which can better meet diverse clinical needs. However, this leading advantage is not unshakable. Currently, two companies in China, Chengdu Aobang Pharmaceutical and Chengdu Leer Pharmaceutical, have submitted applications for the marketing of Brivaracetam as a Category 3 generic drug, both of which are in the review and approval stage. According to industry practices, these two companies are highly likely to apply for both tablet and injection forms simultaneously, meaning that Corey Pharmaceutical's "first-to-market" window period may only last 6-12 months, and subsequent market competition will intensify rapidly.

From a clinical value perspective, the "oral + injectable" dual-formulation strategy of brivaracetam does indeed offer significant clinical advantages. The treatment of epilepsy has distinct phased characteristics: the acute phase requires rapid seizure control via an injectable formulation, while the stable phase necessitates maintenance therapy through an oral formulation. The combination of both formulations enables a seamless transition between "acute-phase control and stable-phase maintenance," offering patients more flexible and convenient treatment options, which can also improve treatment adherence. Particularly for patients in the acute phase who cannot receive oral medication, the addition of an injectable formulation fills a critical gap in clinical treatment, demonstrating differentiated clinical value.

However, against the backdrop of the normalization of national centralized procurement in China, the commercial value of a dual-formulation strategy needs to be viewed rationally. If brivaracetam is included in the national centralized procurement in the future, its pricing will be based on the core principle of "lowest price wins." A dual-formulation strategy may not bring additional price premiums for companies but will instead manifest as an advantage in hospital compatibility — meeting the needs of different treatment scenarios within hospitals and enhancing the product's competitiveness for inclusion in hospital formularies, rather than simply relying on formulation differences to achieve higher profits. Moreover, with the entry of subsequent competitors, if multiple companies adopt a dual-formulation strategy, this approach will transition from a "differentiating advantage" to a "market competition standard." At that point, a company’s core competitiveness will return to more fundamental aspects like cost control and formulation technology.

This has also sparked deep reflection within the industry: the differentiated strategies of China-produced generic drug companies should not be limited to dosage form extensions but should focus on breakthroughs in core technologies. The case of Brivaracetam shows that an exclusive market position is temporary — once subsequent competitors receive approval, the market will quickly shift to price competition, and simple differences in dosage forms are insufficient to create long-term competitive barriers. True differentiation should stem from cost advantages brought by self-production of active pharmaceutical ingredients (API), quality advantages achieved through optimized formulation processes, or increased clinical value via combination innovation or dosage form improvements. Only in this way can companies establish a firm foothold amidst fierce market competition.

3. Behind the First-to-Market Generic Competition —— Speed, Strategy, and Sustainability

CorePharm Achieves Approval for Two Key Varieties in a Single Day: Not by Chance, but by Precise Strategy and Efficient Execution. Since the beginning of this year, CorePharm has significantly accelerated its approval pace, with five varieties already approved and considered to have passed the consistency evaluation. Among these approvals are the first generic version of Abemaciclib, the first approval for Brivaracetam Injection, and Ursodeoxycholic Acid Oral Suspension (the second China-produced option), showcasing the company’s robust R&D and submission capabilities. However, CorePharm's rapid development is not an isolated case within the industry—other leading generic drug companies in China, such as Zhengdatianqing, Qilu Pharmaceutical, and CSPC, are also aggressively competing in the race for first generics, pushing the first-generic competition into a white-hot phase.

But what is worth warning is that the "value decay curve" of the first generic drug is becoming steeper. In the past, due to the long review and approval cycle, the first generic drug companies often enjoyed a market exclusivity period of 1-2 years, quickly capturing market share with the first-mover advantage and obtaining substantial profits; nowadays, with the continuous deepening of China's drug review and approval system reform, the review speed has greatly improved, and the time gap for multiple companies to report production has been continuously shortened, which has significantly compressed the market exclusivity period of the first generic drug, and the first generic window period of some varieties has even been shortened to 6 months or less. Taking Abemaciclib as an example, CorePharm was the first to be approved, but Qilu Pharmaceutical Co., Ltd. followed closely. If Qilu gets approval within half a year, CorePharm’s first-mover advantage will be greatly reduced, and the market competition between the two will directly enter a white-hot stage, significantly lowering the "scarcity value" of the first generic.

This shift is driving the competitive landscape of China's generic drug industry to evolve from a "race for speed" to a "competition of comprehensive strength." In the past, the core competitiveness of enterprises focused on "who can file for production first and who can get approval first." However, with the shortening of the first-to-market window, a pure speed advantage alone can no longer sustain a company’s long-term development. The focus of competition has now shifted to "who can better control costs and who can achieve broader market coverage." The national centralized procurement system is increasingly assertive in determining the pricing power of generic drugs. Whether it is a first-to-market generic or subsequent generics, companies must possess strong cost-control capabilities if they want to stand out in the procurement process and achieve market growth. At the same time, terminal channel coverage and academic promotion capabilities have also become crucial—only by quickly pushing products into hospitals and gaining recognition from doctors and patients can companies seize advantageous market shares in fierce competition, and even surpass first-to-market players.

This also brings profound reflection to China-produced generic drug companies: enterprises should not be overly obsessed with the "first-to-market generic" label, but should rationally consider the long-term development positioning of generics. Currently, the "involution" within the generic drug industry is intensifying, and the development model of crowding into mature varieties and simply competing on approval speed can no longer keep up with industry trends. In the future, the competition among generic drug companies will shift towards three directions: First, high-end difficult-to-copy products, focusing on complex formulations and advanced generics with high technical barriers and significant R&D challenges, avoiding homogenized competition; Second, differentiated dosage forms, meeting unmet clinical needs through formulation improvements and strategic combinations, creating unique competitive advantages; Third, modified new drugs, enhancing the clinical value of medicines through technological innovation based on generic production, achieving a leap from "generic" to "innovation."

For CorePharm, the approval of these two key varieties marks an important milestone in the company's development, but it is merely the starting point for long-term growth. How to leverage the first-mover advantage of being the first generic version of Abemaciclib to quickly build channel and academic strengths; how to consolidate its market position in the anti-epilepsy field by relying on the dual formulations of Brivaracetam; and how to maintain an edge in the race for first generics while planning for long-term differentiated development will be the core issues the company needs to address in the future. For China’s domestic generic drug industry as a whole, the case of CorePharm also offers valuable lessons — only by balancing speed with strategy, and focusing on differentiation and sustainability, can companies achieve high-quality development amidst fierce market competition.

Conclusion

Two new products approved in one day seems like a victory for a certain company, but in fact, it is a microcosm of the overall acceleration of China's local generic drug industry. The first generic drug brings price reductions and improved accessibility, but the window period is shortening; dual dosage forms create a short-term advantage, yet it is difficult to withstand the encirclement of latecomers. For the industry, the real challenge is not about "who gets there first," but "after getting there, how to truly get patients and doctors to use it." After all, approval is just the starting point; the market is the ultimate goal.

Reference: NMPA official website; China Drug Evaluation Database; Mosecure Medicine Database