On July 10, 2026, HANSOH PHARMA announced that its self-developed B7-H3 ADC, Risvutatug Rezetecan (HS-20093), met the primary endpoint of overall survival (OS) in the pivotal Phase III ARTEMIS-008 study for small cell lung cancer.

The comparator drug was topotecan, the long-standing standard regimen for later-line small cell lung cancer. In the pre-specified interim analysis, HS-20093 demonstrated a statistically significant improvement in OS compared to topotecan, achieving clinically meaningful survival benefits. Consistent benefits were also observed in secondary endpoints including progression-free survival (PFS), with a safety profile in line with previous studies and no new safety signals identified.

This marks the first B7-H3 ADC globally to demonstrate an OS benefit in a Phase III clinical trial.

While top-line results have been announced, specific data including hazard ratio, median OS, subgroup benefits, and detailed safety information will await disclosure at subsequent medical conferences. Nevertheless, this represents the first time a novel target previously supported mainly by early-phase data has achieved the rigorous endpoint of OS in a randomized, controlled Phase III study.

Transitioning from generics to innovative drugs, and from domestic sales to global licensing, HANSOH PHARMA has, in a notably understated manner, established itself as one of the most discerning and steadfast players in China's biopharmaceutical global expansion.

This journey has taken the company nearly a decade.

Pioneering B7-H3 ADC Achieves Positive Phase III OS Outcome

Small cell lung cancer accounts for approximately 15% of all lung cancer cases and is characterized by high aggressiveness, rapid progression, and frequent recurrence. Most patients progress rapidly even after first-line platinum-based therapy, leaving very limited treatment options in the second-line and later settings.

Progress in later-line treatment for small cell lung cancer has been slow for a long time. Although new options like lurbinectedin and talazopar have emerged in recent years, regimens that can significantly improve overall survival in randomized Phase III studies remain limited. ARTEMIS-008 is the first to demonstrate that a B7-H3 ADC can deliver a clear overall survival benefit in this disease.

HS-20093 targets the B7-H3 antigen on tumor cell surfaces, using an antibody to deliver a topoisomerase I inhibitor payload directly into cancer cells. Prior ARTEMIS-001 study provided strong early efficacy signals. As of June 2024, in the 8.0 mg/kg and 10.0 mg/kg dose groups, objective response rates were 61.3% and 50.0% respectively, with median PFS of 5.9 months and 7.3 months. Updated results published in Cancer Cell in 2026 showed a confirmed ORR of 52.3% in 65 evaluable patients with extensive-stage small cell lung cancer.

While early studies proved the drug's ability to shrink tumors, ARTEMIS-008 further demonstrates that this effect translates into prolonged patient survival. This is the true value of a positive OS result. Many drugs show high response rates in early studies but fail to extend survival in large-scale randomized trials. HANSOH PHARMA directly chose OS as the primary endpoint, and the result achieved both statistical and clinical significance in the pre-specified interim analysis.

The global push for this drug is driven by a dual-track development strategy, both within and outside China.

In December 2023, HANSOH PHARMA licensed the global rights to HS-20093 outside Greater China to GSK, receiving an upfront payment of $185 million and becoming eligible for up to $1.525 billion in milestone payments plus sales royalties.

GSK initiated an overseas Phase I study in Q3 2024 and a global Phase III study in relapsed small cell lung cancer in Q3 2025. The timeline from signing to overseas clinical initiation was less than a year, and entering global Phase III trials took less than two years. GSK is also expanding HS-20093's development into gastrointestinal cancers, genitourinary cancers, and combination therapies, evolving the global program from a single indication to a multi-tumor strategy.

Regulatory recognition has also been frequent. According to company materials, HS-20093 has received a total of 11 designations including Breakthrough Therapy, PRIME, Priority Review, or Orphan Drug status in China, the US, Europe, and Japan. Its clinical results have also been selected for ESMO Presidential Symposium and AACR Clinical Trials Plenary presentations.

For this Chinese-originated molecule, development and registration within China is led by HANSOH PHARMA, while GSK builds the global clinical network abroad. The speed of the partner has become a part of the asset's quality profile.

A Clear Path to Globalization: Six Key Licensing Deals

HS-20093 is just one piece of HANSOH PHARMA's global expansion puzzle. Examining its transactions over recent years provides a clearer view of the company's strategic judgment.

In October 2023, the company licensed its B7-H4 ADC, HS-20089, to GSK for an $85 million upfront payment and potential milestones up to $1.485 billion. Two months later, the B7-H3 ADC HS-20093 was again licensed to GSK. GSK subsequently accelerated both programs in parallel; based on global Phase I data, HS-20089 is planning to initiate five pivotal Phase III studies in 2026.

In December 2024, the oral small molecule GLP-1 receptor agonist HS-10535, still in the preclinical stage, was licensed to Merck & Co. for a $112 million upfront and potential milestones up to $1.9 billion. This deal, struck before clinical data emerged, shows multinational pharmaceutical companies beginning to value HANSOH PHARMA's early-stage discovery capabilities.

In June 2025, overseas rights to the GLP-1/GIP dual receptor agonist HS-20094 were granted to Regeneron for an $80 million upfront and potential milestones up to $1.93 billion. This drug completed its Chinese Phase III study for weight loss and submitted an NDA in 2026.

In October of the same year, Roche secured rights to the CDH17 ADC HS-20110 outside Greater China for an $80 million upfront, with HANSOH PHARMA eligible for additional milestone payments and sales royalties based on development, registration, and commercialization progress. In December, development and commercialization rights for Ameile (aumolertinib) in multiple overseas regions were licensed to Glenmark, with potential regulatory and commercial milestones exceeding $1 billion.

From October 2023 to the end of 2025, over two years, six licensing deals were signed. Partners include GSK, Merck & Co., Regeneron, Roche, and Glenmark, covering assets in ADCs, oral small molecules, and peptide-based metabolic drugs.

The journey of Ameile particularly illustrates HANSOH PHARMA's approach to globalization. In 2020, its overseas rights were licensed to EQRx. In 2023, EQRx adjusted its strategy and returned the rights. HANSOH PHARMA took over the overseas registration process, subsequently securing approval for Ameile in the UK in 2025 and the EU in 2026, before re-organizing commercialization partnerships for some overseas markets.

This process involved setbacks but helped the company build capabilities beyond pure licensing. When the partner changed, HANSOH PHARMA was able to reclaim the asset, continue advancing regulatory review, and bring a domestically mature product into the European market.

These deals also share a common characteristic. HS-20089, HS-20093, HS-10535, HS-20094, and HS-20110 are at different development stages and cover diverse technological platforms, yet they have successively passed the due diligence of major global pharmaceutical firms. HANSOH PHARMA is now exporting a repeatable capability in project selection and R&D translation.

A recent report summarized the globalization paths for Chinese healthcare companies into three routes: generating direct overseas revenue, sharing global value through licensing-out, and evolving from a domestic leader into a global player. HANSOH PHARMA is quietly pursuing its own path by combining the first two approaches. The company's existing licensed projects correspond to potential milestone payments totaling approximately $9 billion.

These amounts are contingent on clinical, regulatory, and sales conditions and cannot be directly viewed as future revenue. Their value depends on partners successfully advancing the projects through key clinical stages. The Phase III success of HS-20093 is now moving HANSOH PHARMA's business development narrative beyond upfront payments into the clinical validation phase.

The Growth Engine Shifts: Innovative Drugs Rise from 18% to 82%

Global expansion is the outcome; the internal revenue structure and R&D system are the core.

In 2020, revenue from innovative drugs at HANSOH PHARMA accounted for about 18.0%. By 2023, the company began disclosing revenue from innovative drugs and partnered products, which reached 67.9%. This figure climbed to 77.3% in 2024 and further to 82.2% in 2025. The latter two periods include revenue from partnered products, creating some differences from earlier data, but the clear trend is that innovative businesses have become the absolute pillar of revenue.

In 2025, the company achieved revenue of RMB 15.028 billion, a year-on-year increase of 22.6%. Revenue from innovative drugs and partnered products reached RMB 12.354 billion, up 30.4% year-on-year. Net profit was approximately RMB 5.555 billion, a 27.1% increase. R&D investment for the same period reached RMB 3.358 billion, up 24.3% year-on-year, accounting for 22.3% of revenue.

These numbers indicate that HANSOH PHARMA's business development is built upon a continuously growing innovative drug business and sustained R&D investment. Upfront payments supplement cash flow, clinical milestones provide follow-on income, sales royalties retain long-term rights post-commercialization, and the recycled funds support the next wave of projects.

This revenue structure has been described as a "three-layer cake" for business development. The market most easily sees the upfront payment layer. Development, registration, and sales milestones form the second layer. Post-commercialization sales royalties constitute the longest-duration layer. Most milestones are triggered gradually over several years following a deal as projects progress, though risks of clinical failure and regulatory delays remain.

An industry report noted that after the peak of out-licensing fervor in 2025, the market would re-examine companies' product sales and fundamental R&D capabilities. Its pipeline scoring system evaluates breadth, maturity, and innovation, placing HANSOH PHARMA among the top tier of large Chinese pharmaceutical companies.

This also distinguishes HANSOH PHARMA from companies that rely solely on a single transaction to boost profits. It has domestic innovative drug sales providing a foundation, multiple self-developed pipelines ensuring future supply, and several global partners sharing the burden of overseas development and commercialization.

Licensing income may fluctuate, but the capability to output high-quality assets can be sustained.

The Steady Innovator: Often the One That Goes the Farthest

A recent report highlighted that the narrative for Chinese innovative drug globalization has shifted from licensing stories to execution. The next round of value validation will depend on whether companies can advance differentiated assets into globally credible clinical programs and ultimately achieve regulatory and commercial success.

ARTEMIS-008 represents precisely such a validation point.

It validates HANSOH PHARMA's selection of the B7-H3 target and the potential for Chinese clinical data to translate into global development. GSK rapidly initiated overseas Phase I and Phase III studies after signing, incorporating HS-20093 into multiple solid tumor programs. HANSOH PHARMA retained rights in China, advancing its Biologics License Application based on domestic Phase III results. The division of labor between the two parties is beginning to resemble a mature global development model.

From Ameile's entry into the UK and EU markets, to six licensing deals in two years, and the parallel Phase III development of HS-20093 both in China and abroad, HANSOH PHARMA has woven R&D, clinical development, business development, and commercialization into a complete chain.

The positive ARTEMIS-008 result marks the first time this chain has reached a pivotal registration milestone. The readout of one Phase III trial validates a decade of sustained investment.

HANSOH PHARMA's global expansion is not built on hype. In the long-distance race of Chinese innovative drug development, the steadiest runners are often the quietest.

The company has entrusted the answer to time, and time is gradually sending its reply.