The emergence of domestically produced autoimmune drugs has come faster than expected.

In 2024, four domestically produced autoimmune biological agents were approved, ending the previous "frozen" state of having no drugs and ushering in the first watershed moment. Hengrui Medicine, Connoya, Zhixiang Jintai... the names of domestic pharmaceutical companies began to appear on the autoimmune drug landscape.

Accompanying this is a collective start for China to avoid "target differentiation and starting on the same track".

Globally, the autoimmune field is a breeding ground for blockbuster drugs, catalyzing the emergence of numerous multinational pharmaceutical companies (MNCs) with market capitalizations exceeding $100 billion. Currently, the performance of major pharmaceutical companies such as AbbVie, Sanofi, and UCB is still dominated by autoimmune single products. Just a few days ago, Sanofi's Q1 2026 financial report showed that its flagship product, dupilumab, generated $4.874 billion in sales in a single quarter, representing a year-on-year increase of 30.8%.

Today, innovative Chinese drugs are also knocking on the door of this multi-billion dollar market.

Over the past few years, technological accumulation, pipeline investment, and market cultivation have gradually become complete. The pioneers in the self-free track have not only produced blockbuster potential products in commercialization, but have also made frequent moves in overseas business development, officially entering a period of explosive growth centered on intensive pipeline development, the formation of a commercial ecosystem, and the advancement of globalization capabilities.

Domestically produced autoimmune drugs are already showing their potential.

01
Commercialization ramp-up of top players

As the second largest market after oncology, autoimmune diseases are diverse, including about 100 different diseases such as atopic dermatitis (AD), psoriasis (PsO), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE), affecting about 5%-8% of the global population. The global market is currently close to US$150 billion.

Focusing on the domestic market, China has a large population suffering from autoimmune diseases, but the penetration rate of biologics is less than 30%, far lower than in Europe and the United States, indicating huge potential for market growth. In the long term, especially considering the low penetration rate of biologics, the Chinese autoimmune drug market has even greater potential for growth.

2025 is a banner year for domestically produced autoimmune products, with many products achieving key clinical breakthroughs or commercialization, becoming the core support for the industry's organic growth.

Data shows that more than 20 domestically produced immunotherapeutic drugs have obtained regulatory approval in China, and more than 10 other new drugs have submitted marketing applications. The types of drugs cover monoclonal antibodies, bispecific antibodies, chemical drugs and antibody fusion proteins, and the targets involved include IL-17A, IL-4Rα, CD20, JAK1, TPOR and others.

Hengrui Medicine has successively obtained approval for three autoimmune products: funacizumab (IL-17A), imaxitinib (JAK1), and hetrombopag ethanolamine (TPOR), covering multiple indications such as psoriasis, ankylosing spondylitis, atopic dermatitis, and immune thrombocytopenic purpura, making it the domestic pharmaceutical company with the most approved products to date.

Connoya 's sprojibaumab, as the first domestically approved IL-4Rα monoclonal antibody, has avoided direct competition with dupilumab by leveraging its differentiated strategy for the indication of seasonal allergic rhinitis, and has successfully gained popularity on social media, earning it the nickname "rhinitis injection" in the industry.

Despite not being included in the national medical insurance program in 2025, sales of Sprozibayumab surged by 775% year-on-year, reaching 315 million yuan. With the product being included in the national medical insurance catalog in December 2025, 2026 will be the first full year for its increased market share under medical insurance, highlighting the certainty of this significant increase.

Zhixiang Jintai 's celecoxib (IL-17A) saw rapid sales growth, with sales exceeding 200 million yuan in 2025. Leveraging its price advantage under the medical insurance program, it quickly became a leading domestic product in the psoriasis field, accelerating the import substitution process and driving steady growth in the company's overall revenue. The net loss attributable to the parent company continued to narrow, and the next core product, telizimab (IL-4Rα), is about to be commercialized.

3SBio received approval for Ammicitabine (IL-17A), becoming the only IL-17A inhibitor in China that can be administered once every 8 weeks during the maintenance period, demonstrating significant competitive advantages.

Quanxin Biotech 's Cyrexin (ustekinumab biosimilar) achieved sales of nearly 300 million yuan in its first full calendar year, helping the company turn a profit. It is expected to reach 500 million yuan in 2026, fully demonstrating the commercial potential of domestically produced autoimmune biosimilars.

Overall, domestically produced autoimmune drugs have entered a stage of "simultaneous volume expansion of multiple products." However, compared to blockbuster drugs in the global autoimmune market that often generate tens of billions of dollars in revenue, domestic products are still in the early ramp-up phase , and true commercialization will take time.

Moreover, it is worth noting that, unlike the "rapid outbreak - intense competition" path in the field of oncology, autoimmune drugs rely more on "long-term ecosystem cultivation" and "refined operation" due to the large patient base, the need for long-term drug treatment, and the difficulty in achieving a complete cure.

From this perspective, the exploration and value breakthrough of China's self-reliant innovation ecosystem has only just begun.

In addition to the aforementioned commercialized products, there are other products in the market review stage, including Bio-Thera's CD20 monoclonal antibody BAT4406F (Darpubayumab), Quanxin Bio's IL-17A monoclonal antibody Rucecitaumab (QX002N), Hisun Pharmaceutical's CFB inhibitor HSK39297, and Livzon Pharmaceutical's IL-17A/F dual-target inhibitor Lyconcitaumab , etc. These pipelines will provide continuous ammunition for the next stage of competition.

02
Golden window for BD trading

If commercialization and scaling up are the "internal skills training" in the domestic market, then overseas business development is the main battlefield for Chinese self-medicated pharmaceutical companies to prove their value to the outside world.

Globally, major products in the self-free technology sector are facing a patent cliff.

AbbVie's adalimumab's US exclusivity expired in 2023; Johnson & Johnson's ustekinumab patent expired in 2024, and biosimilar competitors have entered the market; Novartis' secukinumab core patent will expire in the US in 2029; Sanofi's dupilumab is projected to have global sales of approximately $18.8 billion in 2025, with its patent expiring as early as 2031.

This series of core assets is converging on the patent cliff, strongly driving MNC to accelerate its deployment of next-generation innovative therapies and search for autoimmune assets worldwide—opening a historic window of opportunity for Chinese autoimmune innovative drugs to go global.

From 2025 to 2026, a number of domestic self-exempt asset BD transactions were successfully completed, with several landmark cases emerging.

The most sensational of these was the record-breaking collaboration between Hengrui Medicine and GSK.

In July 2025, Hengrui Medicine granted GSK the global exclusive rights (excluding Greater China) to its PDE3/4 inhibitor HRS-9821 and global exclusive options for up to 11 pipeline projects through an innovative model of "core project licensing + pipeline options". The initial payment was US$500 million and the potential total transaction amount was as high as US$12.5 billion.

HRS-9821 is a potential "best-in-class" PDE3/4 inhibitor independently developed by Hengrui. Early data have confirmed that it can synergistically enhance bronchodilatory and anti-inflammatory effects by potently inhibiting the dual targets of PDE3 and PDE4, while also enabling the development of dry powder inhaler (DPI) formulations and improving clinical convenience.

Not only large pharmaceutical companies, but also Biotech, which has been deeply involved in the autoimmune industry for many years, are showing great activity.

In 2025, Quanxin Bio achieved three major milestones with its three long-acting bispecific antibody pipelines . Among them, the global exclusive collaboration with Roche on QX031N (TSLP/IL-33 bispecific antibody) has an upfront payment of up to US$75 million and a total potential milestone value of US$1.07 billion.

Also mentioned above , Zhixiang Jintai reached an important licensing agreement last June : Cullinan Therapeutics acquired the global rights to its BCMA×CD3 bispecific antibody Velinotamig (GR1803) outside of Greater China, with an upfront payment of US$20 million and a potential total amount of US$712 million.

In addition to the product pipeline itself, platform-based collaborations are also beginning to emerge.

On January 5, Earendil Labs, the overseas subsidiary of Huashen Zhiyao, announced a strategic collaboration with Sanofi to apply its discovery platform to multiple autoimmune and inflammatory disease projects . In return, the company will receive a near-term upfront payment and early-stage milestone payments of $160 million, with a potential total transaction value of $2.56 billion.

This marks the second major collaboration between the two companies regarding bispecific antibodies against autoimmune diseases. Back in April of last year, Sanofi had already acquired the global rights to two bispecific antibodies from Huashen Zhiyao – this further significant investment demonstrates the multinational giant's continued optimism about domestically developed technology platforms.

In addition to product licensing and platform cooperation, domestically produced autoimmune drugs have also achieved overseas listing through independent or cooperative means, building a complete overseas expansion path of "overseas licensing → overseas listing".

In January of this year, Bio-Thera Solutions received milestone payments of $10 million from its US partner (Hikma) and $2.5 million from its European partner (Gerry Pharmaceuticals) as its ustekinumab biosimilar (BAT2206) was approved for marketing by the US FDA and the European EMA, respectively, and began commercialization.

In February, another biosimilar drug, golimumab injection (BAT2506), was approved by the European Union for the treatment of autoimmune diseases such as rheumatoid arthritis. Through collaborations with companies such as Stada, it has reached 115 countries and regions, becoming Bio-Thera's second autoimmune drug to be marketed in the EU.

Overall, domestically produced autoimmune drugs cover a variety of drug forms, including monoclonal antibodies, bispecific antibodies, small molecules, and fusion proteins. Among them, the research and development progress in the field of bispecific antibodies is leading the world, forming a unique technological advantage and becoming the preferred partner for multinational pharmaceutical companies.

Meanwhile, globalization is key for domestic pharmaceutical companies to break through the ceiling of the domestic market. The industry has now upgraded from single product overseas licensing to a diversified model of "product export + platform cooperation + overseas listing" , and the process of going global continues to accelerate.

03
The second half of self-exemption from competition

With initial success in commercialization and a series of business development (BD) moves overseas, domestic autoimmune drug companies seem to have caught the wave. But the real battle has only just begun. Who will emerge victorious in this crowded arena?

In its research report, Haoyue Capital pointed out that the future development of autoimmune drugs will inevitably move towards an era of "precision stratification" treatment. New entrants must begin by clearly identifying unmet needs and establish a clear clinical and commercial closed loop around verifiable differentiated value.

The research report by Guotai Haitong Securities believes that the next generation of autoimmune products will undergo comprehensive technological iterations in three dimensions: effectiveness, safety, and compliance , helping patients establish better medication habits, prolonging DOT (duration of treatment), and further opening up the autoimmune market space.

Specifically, in terms of iterative development of mature targets, long-acting formulations and oral alternatives are accelerating.

Connoya's CM512 (IL-13/TSLP bispecific antibody) has already shown promising early clinical data; 3SBio's Ambroxol (IL-17A) has achieved dosing once every 8 weeks; next-generation oral small molecule drugs such as TYK2 inhibitors are catching up with the efficacy of biologics due to their oral convenience, and many companies such as Yifang Bio, Innovent Biologics, and Highlight Pharmaceuticals are actively investing in this field.

Meanwhile, new targets also provide structural opportunities for newcomers. TL1A has both anti-inflammatory and anti-fibrotic effects in the field of IBD, and 3SBio is leading in clinical trials in China; in areas such as STAT6 and IRAK4, many innovative drug R&D entities in China, such as Lingke Pharmaceutical and Lingtai Bio, are actively developing cutting-edge pathways such as PROTAC.

In addition, new modalities such as TCE, CAR-T, and small nucleic acids are constantly expanding into the autoimmune field, rewriting the triangular relationship of "efficacy-safety-convenience" into a new competitive dimension.

For example, Qihan Biotech's CD19/BCMA dual-target universal CAR-T therapy QT-019B clinical trial has been approved in both China and the United States, with its first indication being refractory systemic lupus erythematosus. This signifies that China's international frontier layout in CAR-T autoimmune applications is continuing to deepen.

From a business and market perspective, future competition will no longer be about who launches their product first, but about who can use a clearer business model to successfully navigate the entire chain from "clinical value" to "market share" and then to "sustainable profits".

For domestic autoimmune drug companies, the starting point for project initiation must be a precise insight into unmet clinical needs—first identifying the most easily verifiable patient groups and endpoints, and then working backward to deduce the targets and drug formulations. While mature downstream targets can quickly contribute cash flow, their potential is limited; new upstream targets, on the other hand, need to overcome efficacy thresholds through biomarker enrichment or dual-target combination designs.

The companies that truly possess long-term competitiveness are those that can build barriers to entry in a red ocean market through differentiation, win global trust with high-quality, internationally replicable clinical data, and ultimately realize value through business development or independent commercialization.

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