The autoimmune sector is emerging as one of the hottest tracks for innovative drug investment, with synchronized warming in both primary and secondary market transactions. Latest statistics show that in the first half of 2025 alone, the total transaction value of License-out deals for Chinese innovative drugs approached $66 billion, surpassing the entire BD transaction scale of 2024 and setting a new historical record.

Immunological drugs represent the world's second-largest prescription drug market after oncology, with BD proportions increasing. From 2023 to 2024, the proportion of overseas licensing transactions for oncology pipelines declined from 72% to 61%, while metabolic and autoimmune segments increased from 12% to 25%, nearly doubling in expansion.

The surge in transaction activity has naturally fostered numerous high-quality targets. In this wave, QYUNS-B (02509), which recently delivered impressive interim results, stands as one of the most representative cases.

**Revenue Surges 3.5 Times, Pipeline Transitions from Monoclonal 1.0 to Bispecific 2.0**

QYUNS-B was established in 2015 as a biotechnology company specializing in biological therapies for autoimmune and allergic diseases, comprehensively covering four major areas: dermatology, respiratory, digestive, and rheumatology.

Benefiting from core product commercialization and external BD activities, QYUNS-B achieved significant performance growth in the first half. Financial reports show that QYUNS-B realized revenue of RMB 206 million in H1 2025, surging 359.69% year-over-year. The substantial revenue growth primarily stemmed from upfront payments, milestone payments, clinical R&D service fees, and CDMO revenue from external licensing projects.

Moreover, QYUNS-B's loss situation improved significantly, with adjusted losses of RMB 5.221 million during the period, a substantial 96% reduction compared to the same period last year. The company also maintains robust cash flow, with cash and cash equivalents of approximately RMB 559 million as of June 30, 2025.

Currently, QYUNS-B has one commercialized product: Celexin®, China's first ustekinumab biosimilar. Celexin® received National Medical Products Administration approval for market launch in October 2024. As of June 2025, QYUNS-B had delivered over 60,000 units to China Resources Huadong (a wholly-owned subsidiary of Huadong Medicine). A supplemental application for pediatric plaque psoriasis indication was approved in March 2025. Additionally, marketing authorization applications and supplemental applications for Crohn's disease were accepted in February 2025.

During the first half, QYUNS-B's research pipeline achieved multiple milestones. Lead product QX005N (IL-4Rα monoclonal antibody) has obtained IND approval for seven indications, becoming one of the IL-4Rα targeted candidate drugs with the most indications in China, and one of only two domestic products targeting this site to receive Breakthrough Therapy Designation (BTD).

In March 2025, QX005N completed patient enrollment for its Phase III trial in nodular prurigo (PN) in China, while patient enrollment for atopic dermatitis (AD) Phase III trial in China is nearing completion. Both clinical trials are expected to read out primary endpoint data by the end of this year and early next year, respectively.

QX002N (IL-17A monoclonal antibody), the first innovative drug developed through the proprietary antibody platform, achieved its primary endpoint in Phase III clinical research for ankylosing spondylitis treatment in February 2025, with BLA submission planned within this year.

QX004N (IL-23p19 monoclonal antibody) and QX008N (TSLP monoclonal antibody) are respectively in Phase III clinical stage for psoriasis (Ps) and Phase II clinical stage for chronic obstructive pulmonary disease (COPD) domestically. Partners Hansoh Pharma and Health-Joint are accelerating development, with overall progress ranking among the domestic forefront.

Looking globally, autoimmune disease treatment is entering the "Bispecific 2.0" era - while no autoimmune bispecific antibody has been approved to date, it is already viewed as the track with the most potential to reshape market landscape after PD-1, potentially giving birth to the next "Humira"-level blockbuster product.

Leveraging over a decade of deep cultivation in the autoimmune field, QYUNS-B has pioneered the pipeline transition from "Monoclonal 1.0" to "Bispecific 2.0": forming a reserve of four potentially global first-in-class or best-in-class long-acting bispecific antibodies, with three to be submitted for IND within this year, constructing a clear-rhythm, progressive-risk "matrix-style" development pathway, aiming to secure positioning as the next-generation autoimmune leader.

**Domestic Commercial Acceleration + BD Overseas Expansion, TruMed Investment Placement Entry**

Beyond impressive R&D pipeline performance, QYUNS-B's commercialization capabilities stand out prominently among biotech companies.

QYUNS-B's second-largest shareholder is Huadong Medicine. Huadong Medicine's sales network spans over 30 provinces (autonomous regions, municipalities), with over 10,000 sales personnel. Therefore, in the domestic market, QYUNS-B can sell products through Huadong Medicine's sales channels, thereby accelerating commercialization pace.

For instance, QYUNS-B's commercialized Celexin®, under Huadong Medicine's sales efforts, has reached over 1,200 prescription-issuing hospitals in the first half, with market sales gradually accelerating.

In international markets, the company leverages BD for "shipbuilding and overseas expansion." In April 2025, QYUNS-B licensed global rights for long-acting autoimmune bispecific QX030N to Caldera, receiving $10 million upfront, 24.88% equity, up to $545 million in milestones, and tiered sales royalties. This represents an important step in QYUNS-B's overseas strategy, with the company emerging prominently in the global autoimmune bispecific field through the NewCo approach.

Notably, QX030N is expected to submit IND within the year, possessing secondary BD potential, and the company's subsequent pipeline includes multiple autoimmune bispecific products, with continued BD prospects ahead.

In the domestic market, relying on Huadong Medicine's nationwide sales force, QYUNS-B's domestic commercialization engine has started at full speed. Simultaneously, the company "borrows ships for distant sailing," rapidly expanding bispecific antibody territories globally through BD transactions, bringing stronger certainty to future cash flow expectations.

Additionally, the company's CDMO business (Cypher production base) and external R&D services contributed approximately RMB 22 million in revenue in the first half, with potential for continued volume growth in 2025, providing sustained funding for innovative pipelines.

Adding further confidence, QYUNS-B recently received significant investment from TruMed Health Innovation Fund LP in a placement. It's worth noting that TruMed Investment has previously participated as a cornerstone investor in prominent Hong Kong biotech projects including CStone Pharmaceuticals, Ying En Biologics, VivaBiotech, and Mylike, earning recognition as a bellwether for Hong Kong healthcare IPO investments. This investment provides strong institutional endorsement for QYUNS-B and adds market confidence in the company's long-term value.