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Domestic Autoimmune Drugs Begin to Shine

Apr 30,2026

The breakout of domestic innovative autoimmune disease drugs has come faster than expected.

In 2024, four domestic autoimmune biological agents gained regulatory approval in quick succession, ending the prolonged "frozen era" of limited treatment options and marking the first watershed moment for the sector. Names of Chinese pharmaceutical enterprises—including Hengrui Medicine, Canova Biopharma, and Zhixiang Jintai—have begun to emerge on the global autoimmune disease treatment landscape.

Parallel to this trend is the accelerated formation of China’s three-dimensional innovation system for autoimmune drugs: target differentiation, molecular engineering, and refined clinical strategy design.

This is not an isolated batch of breakthroughs, but a collective starting sprint for the entire track.

Globally, the autoimmune disease sector has long been a cradle for blockbuster drugs, spawning multiple multinational corporations (MNCs) with a market capitalization exceeding $100 billion. To this day, the performance of major pharmaceutical giants such as AbbVie, Sanofi, and UCB is still dominated by their flagship autoimmune products. Just days ago, Sanofi’s Q1 2026 financial report showed that its flagship drug dupilumab recorded quarterly sales of $4.874 billion, a year-on-year increase of 30.8%.

Now, Chinese innovative drugs are also knocking on the door of this trillion-dollar market.

Years of technological accumulation, pipeline investment and market cultivation have laid solid foundations. Pioneers in the domestic autoimmune track have not only developed potential blockbuster products in commercialization, but also made frequent overseas business development (BD) deals. The sector has officially entered an explosive growth phase driven by intensive pipeline harvest, maturing commercialization ecosystem and advancing globalization capabilities.

Domestic autoimmune drugs have truly shown their sharp edge.

01、Commercial Volume Growth of Leading Players

As the second largest pharmaceutical market after oncology, autoimmune diseases encompass nearly 100 conditions including atopic dermatitis (AD), psoriasis (PsO), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE), affecting approximately 5%–8% of the global population. The global market size has neared $150 billion.

In China, the patient pool for autoimmune diseases is enormous, yet the penetration rate of biological agents remains below 30%, far lower than that in Europe and the United States, leaving immense room for market growth. In the long run, given the low penetration of biological agents, China’s autoimmune drug market boasts substantial untapped potential worthy of close attention.

2025 stood out as a bumper harvest year for domestic autoimmune products. Multiple candidates completed key clinical milestones or achieved robust commercial volume growth, becoming a core driver of endogenous industry growth.

According to Insight Pharma Database, over 20 domestic innovative autoimmune drugs have secured regulatory approvals, with more than 10 additional candidates under marketing application review. These products cover monoclonal antibodies, bispecific antibodies, chemical drugs and antibody fusion proteins, targeting pathways including IL-17A, IL-4Rα, CD20, JAK1 and TPOR.

Since 2024, Hengrui Medicine has obtained approvals for three autoimmune drugs: fulanokibumab (IL-17A), emavitinib (JAK1), and hetrombopag olamine (TPOR). Covering indications such as psoriasis, ankylosing spondylitis, atopic dermatitis and immune thrombocytopenia, it now has the largest number of approved domestic autoimmune products in China.

As China’s first approved IL-4Rα monoclonal antibody, Canova Biopharma’s spulimumab adopted a differentiated layout targeting seasonal allergic rhinitis, avoiding direct competition with dupilumab. It quickly gained popularity on social media and is widely known in the industry as the "rhinitis injection".

Without inclusion in the National Medical Insurance Catalogue in 2025, spulimumab’s sales surged 775% year-on-year to RMB 315 million. Following its inclusion in the catalogue in December 2025, 2026 will mark its first full year of volume expansion driven by medical insurance, with highly certain growth prospects.

Zhixiang Jintai’s selicimab (IL-17A) saw rapid sales growth after being included in medical insurance, exceeding RMB 200 million in 2025. Leveraging price advantages under medical insurance coverage, it has quickly become a leading domestic drug for psoriasis, accelerating import substitution and driving steady revenue growth for the company. Its net loss continues to narrow, while its next core candidate telicimab (IL-4Rα) is poised for upcoming commercialization.

3SBio gained approval for amlitelimab (IL-17A) in early 2025, making it the only domestic IL-17A inhibitor approved for an 8-week maintenance dosing interval, boasting clear differentiated advantages.

Quansin Bio’s seloximab (ustekinumab biosimilar) achieved nearly RMB 300 million in sales in its first full calendar year, turning the company from loss to profit. Sales are projected to reach RMB 500 million in 2026, fully validating the commercial potential of domestic autoimmune biosimilars.

Overall, domestic autoimmune drugs have entered a phase of simultaneous volume expansion across multiple varieties. Nevertheless, compared with global blockbuster autoimmune products that rake in tens of billions of US dollars annually, domestic candidates are still in the early growth stage, with genuine commercial breakout yet to come.

Notably, unlike the oncology sector’s trajectory of "rapid boom followed by intense homogenized competition", autoimmune drugs rely more on long-term ecosystem cultivation and refined operation, given their large patient base, requirement for long-term medication and difficulty in complete cure.

From this perspective, the exploration and value breakthrough of China’s autoimmune innovation ecosystem have only just begun.

Beyond already commercialized products, a robust pipeline is under marketing review, including:

Baiotech’s CD20 monoclonal antibody BAT4406F (dalpobartumab)
Quansin Bio’s IL-17A monoclonal antibody rusechitamab (QX002N)
Haisco’s CFB inhibitor HSK39297
Livzon Pharma’s IL-17A/F dual-target inhibitor laikonchitamab

These pipeline reserves will sustain competition in the next development phase.

02、The Golden Window for BD Transactions

If commercial volume growth represents internal capability building in the domestic market, overseas BD is the main battlefield for Chinese autoimmune pharmaceutical enterprises to demonstrate their global value.

Globally, blockbuster autoimmune drugs are entering a concentrated patent cliff period:

AbbVie’s adalimumab lost its U.S. exclusive patent protection in 2023;
Janssen’s ustekinumab’s patent expired in 2024, with biosimilar competitors entering the market one after another;
Novartis’s secukinumab core patent will expire in the U.S. in 2029;
Sanofi’s dupilumab generated approximately $18.8 billion in global sales in 2025, with its earliest patent expiring in 2031.

The concentrated patent expiration of these core flagship assets is pushing MNCs to accelerate the layout of next-generation innovative therapies and source autoimmune assets globally — opening a historic window for the overseas expansion of Chinese innovative autoimmune drugs.

2025–2026 has witnessed a surge in BD deals for domestic autoimmune assets, with a string of landmark transactions emerging.

The most sensational deal is the record-breaking collaboration between Hengrui Medicine and GSK.

In July 2025, under an innovative model of core project licensing plus pipeline option rights, Hengrui granted GSK exclusive global rights (excluding Greater China) to its PDE3/4 inhibitor HRS-9821, as well as exclusive global options for up to 11 pipeline candidates. The deal includes a $500 million upfront payment, with a total potential value of $12.5 billion.

HRS-9821 is a self-developed potential best-in-class PDE3/4 inhibitor. Early clinical data confirms that it synergistically enhances bronchodilation and anti-inflammatory effects by dual potent inhibition of PDE3 and PDE4, and supports dry powder inhaler (DPI) formulation development for improved clinical convenience.

Beyond large pharmaceutical groups, biotech firms with long-term focus on autoimmune diseases are also highly active.

In 2025, Quansin Bio secured three major global licensing deals for its long-acting autoimmune bispecific antibody pipeline. Its global exclusive collaboration with Roche for QX031N (TSLP/IL-33 bispecific antibody) includes a $75 million upfront payment and total milestone potential of $1.07 billion.

Zhixiang Jintai, mentioned earlier, also sealed a major licensing deal last June: Cullinan Therapeutics obtained global rights outside Greater China to its BCMA×CD3 bispecific antibody velinotamig (GR1803), with a $20 million upfront payment and total potential value of $712 million.

In addition to product pipeline licensing, platform-based cooperation has also emerged.

On January 5, Earendil Labs, the overseas subsidiary of Huashen Zhiyao, announced a strategic collaboration with Sanofi to deploy its drug discovery platform across multiple autoimmune and inflammatory disease programs. The deal brings $160 million in near-term upfront and early milestone payments, with a total potential value of $2.56 billion.

This marks the second major collaboration between the two parties on autoimmune bispecific antibodies. As early as April last year, Sanofi licensed global rights to two autoimmune bispecific antibodies from Huashen Zhiyao. The renewed heavy investment further underscores multinational giants’ sustained confidence in domestic technological platforms.

Apart from product licensing and platform cooperation, domestic autoimmune drugs have also achieved overseas marketing via independent or collaborative pathways, forming a complete overseas expansion model of overseas licensing → global commercial launch.

In January this year, Baiotech’s ustekinumab biosimilar (BAT2206) obtained marketing approvals from the U.S. FDA and European EMA and initiated commercialization. The company received milestone payments of $10 million from its U.S. partner Hikma and $2.5 million from its European partner Geropharm.

Shortly after in February, another biosimilar — golimumab injection (BAT2506) — was approved by the EU for the treatment of rheumatoid arthritis and other autoimmune diseases. Partnered with firms including Stada, it covers 115 countries and regions, becoming Baiotech’s second marketed autoimmune drug in the EU.

Overall, domestic autoimmune drugs cover monoclonal antibodies, bispecific antibodies, small molecules, fusion proteins and other modalities. Chinese R&D in bispecific antibodies is among the global leaders, forming unique technological advantages and becoming preferred partners for multinational pharmaceutical enterprises.

Meanwhile, as globalization layout becomes a key strategy for domestic drugmakers to break domestic market growth ceilings, the industry has evolved from single-product overseas licensing to a diversified model of product export + platform cooperation + overseas marketing, with overseas expansion accelerating steadily.

03、The Second Half of Autoimmune Competition

With initial achievements in commercial volume growth and continuous breakthroughs in overseas BD, domestic autoimmune pharmaceutical enterprises seem to be riding the industry boom. Yet the real decisive competition has only just begun. The key question remains: who will stand out in this crowded track?

According to a research report by Howell Capital, future R&D of autoimmune drugs will inevitably enter an era of precision stratified treatment. Latecomers must initiate project design based on clearly unmet clinical needs, and build a closed-loop clinical and commercial system centered on verifiable differentiated value.

Guotai Haitong Securities holds the view that next-generation autoimmune products will achieve comprehensive technological iteration across three dimensions: efficacy, safety and medication adherence. These advances will help patients form better medication habits, prolong duration of treatment (DOT), and further expand the autoimmune market.

In terms of iteration of mature targets, long-acting formulations and oral alternatives are gaining rapid momentum.

Canova Biopharma’s pipeline candidate CM512 (IL-13/TSLP bispecific antibody) has yielded positive early clinical data;
3SBio’s amlitelimab (IL-17A) has achieved an 8-week dosing interval;
Next-generation oral small-molecule drugs such as TYK2 inhibitors are closing the efficacy gap with biological agents while offering oral convenience. Firms including Yifan Biotech, Nuocheng Jianhua and Highlight Pharma are actively deploying this track.

Meanwhile, novel targets offer structural opportunities for late entrants. TL1A exerts dual anti-inflammatory and anti-fibrotic effects in inflammatory bowel disease (IBD), with 3SBio leading domestic clinical development. Domestic innovative drug developers including Lingke Pharma and Lintai Biotech are advancing cutting-edge R&D modalities such as PROTAC for targets including STAT6 and IRAK4.

Furthermore, novel modalities including TCEs, CAR-T therapy and oligonucleotides are expanding into the autoimmune field, reshaping the competitive landscape by redefining the trade-off between efficacy, safety and convenience.

For instance, Qihan Biotech’s CD19/BCMA universal CAR-T therapy QT-019B has obtained dual clinical trial approvals in China and the U.S., with its first indication targeting refractory systemic lupus erythematosus. This marks China’s deepening layout at the global frontier of CAR-T applications in autoimmune diseases.

From a commercial and market perspective, future competition will no longer be defined merely by speed of product launch. Instead, it hinges on building a sound commercial model to realize the full value chain from clinical value to market share and sustainable profit.

For domestic autoimmune pharmaceutical enterprises, project initiation must start with precise insight into unmet clinical needs: first identify the most verifiable patient populations and clinical endpoints, then reverse-design targets and drug modalities. While mature downstream targets can generate steady cash flow quickly, their growth space is limited. Novel upstream targets require efficacy threshold breakthroughs via biomarker enrichment or dual-target combination design.

Enterprises with long-term core competitiveness are those that can: build moats through differentiation in the red ocean market; gain global recognition with high-quality, internationally replicable clinical data; and ultimately monetize value via BD licensing or independent global commercialization.

References

Howell Capital, In-depth Research Report on Autoimmune Industry: A New Chapter for Domestic Innovative Drugs
Domestic Innovative Autoimmune Drugs: From Domestic Breakthrough to Global Competition, Driven by Dual Engines of Commercialization and Global Expansion
China Merchants Bank Research, Biopharmaceutical Innovative Drugs – Autoimmune Diseases: Rise of Domestic Innovative Candidates
Guotai Haitong Securities, Blockbuster Drug Series on Autoimmune Diseases (I): The Trillion-dollar Autoimmune Track Ushered in Generational Transition, with MNCs Accelerating Layout of Next-Generation Pipelines

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