Roche is paying China’s Hansoh Pharmaceutical US$400 million upfront for antibody-drug conjugate (ADC) programmes that have yet to enter clinical trials. At ESMO in Madrid, MSD and Kelun-Biotech reported a 6.9-month improvement in median overall survival with an experimental ADC in advanced endometrial cancer.

AstraZeneca and Daiichi Sankyo have also secured a new EU approval for Enhertu in early breast cancer, while a separate study produced less encouraging results in a different patient group.

The investments carry different risks. Some back preclinical candidates, while others depend on late-stage results or new indications for approved drugs. Headline deal values say little about which will generate a commercial return.

Visiongain Top Takeaways

• Licensing investment: Roche’s Hansoh agreement includes more than US$15 billion in potential milestones, but the new programmes remain preclinical and their targets are undisclosed.
• Regulatory progress: MSD and Kelun-Biotech’s sacituzumab tirumotecan has secured FDA priority review in endometrial cancer, with a decision expected by 15 June 2027.
• Commercial competition: Enhertu’s new EU approval brings it into direct competition with Roche’s Kadcyla, while safety, pricing and reimbursement will influence uptake.

Roche Broadens Its Hansoh Partnership

Roche’s first Hansoh deal, signed in October 2025, secured rights to HS-20110, a clinical-stage ADC targeting CDH17, for US$80 million upfront. The new agreement covers two preclinical programmes and additional candidates using Hansoh’s technology against targets selected by Roche.

Hansoh will lead development through global Phase Ia trials, with Roche taking over thereafter outside mainland China, Hong Kong, Macau and Taiwan. Hansoh retains rights in those markets and can contribute to the development of up to two programmes elsewhere in return for additional potential US commercial benefits.

Roche will pay another US$110 million after one year, while more than US$15 billion in potential milestones remains conditional. With the new targets and indications undisclosed, their competitive prospects are difficult to assess.

Pfizer’s May 2026 agreement with Innovent Biologics provides a different model. The US$650 million upfront deal covers 12 early-stage oncology programmes, including ADCs and multispecific antibodies. Pfizer and Innovent will share development costs and US and European profits on four jointly developed programmes.

MSD and Kelun-Biotech Move Closer to US Approval

MSD and Kelun-Biotech’s TROP2-targeting ADC, sacituzumab tirumotecan (sac-TMT), has improved survival in patients with advanced or recurrent endometrial cancer previously treated with platinum-based chemotherapy and immunotherapy.

In the global Phase III TroFuse-005 trial, median overall survival reached 19.0 months, compared with 12.1 months for chemotherapy. Median progression-free survival was 7.2 months versus 3.9 months. It is the first global Phase III trial to demonstrate improvements in both measures for a TROP2 ADC in this setting.

Grade 3 or higher treatment-related adverse events were more frequent with sac-TMT (54.4% versus 41.4%), although treatment discontinuation rates were lower (3.1% versus 4.9%).

The FDA has accepted MSD’s application for priority review, with a target decision date of 15 June 2027. MSD is also testing sac-TMT across 18 global Phase III trials, making the endometrial cancer application an important first US regulatory test for its wider development programme.

MediLink’s ADC Delivers Survival Benefit in Lung Cancer

Roche’s January 2026 agreement with MediLink Therapeutics covers tambotatug pelitecan (Tam-Peli), a B7-H3-targeting ADC further advanced than its new Hansoh programmes.

At ESMO, the Phase III TAISHAN-301 trial reported a 50.8% response rate in heavily pretreated recurrent or metastatic nasopharyngeal cancer, compared with 25.8% for physician-chosen treatment. Overall survival data remain immature.

In a separate Phase III trial in relapsed small-cell lung cancer, Tam-Peli extended median overall survival to 13.3 months, compared with 9.4 months for topotecan.

China’s National Medical Products Administration (NMPA) has accepted marketing applications for both indications. Roche holds development and commercialisation rights outside mainland China, Hong Kong and Macau, with global Phase III trials planned.

Competition is already developing. Amgen’s T-cell engager tarlatamab is approved for previously treated extensive-stage small-cell lung cancer in the US and EU. Roche will need international evidence to establish Tam-Peli’s place among available treatments.

Enhertu Challenges Roche’s Kadcyla in Early Breast Cancer

AstraZeneca and Daiichi Sankyo’s Enhertu received EU approval on 27 October 2026 for certain patients with HER2-positive early breast cancer who have residual disease following treatment before surgery. The decision puts Enhertu in direct competition with Roche’s Kadcyla (T-DM1) in this post-surgery setting.

In the Phase III DESTINY-Breast05 trial, three-year invasive disease-free survival was 92.4% with Enhertu, compared with 83.7% for Kadcyla. However, drug-related interstitial lung disease occurred in 9.6% of Enhertu patients versus 1.6% receiving Kadcyla, including two fatal cases with Enhertu.

The approval also triggers a US$75 million milestone payment from AstraZeneca to Daiichi Sankyo, which records sales in most EU markets.

A separate Phase II TALENT trial reported low pathological complete response rates of 3–9% with Enhertu-based treatment before surgery in hormone receptor-positive, HER2-low early breast cancer.

TALENT involved a different patient group from DESTINY-Breast05 and lacked a chemotherapy-only control. Pathological complete response is also a limited measure of benefit in hormone receptor-positive disease, leaving Enhertu’s role in this setting unresolved.

Market Outlook: Where Will ADC Growth Translate into Sales?

Visiongain forecasts the global antibody-drug conjugates market to grow from US$18.42 billion in 2026 to US$55.94 billion by 2036, at a CAGR of 11.8%.

Regulatory approval does not guarantee commercial uptake. In September 2026, NICE recommended Enhertu for HER2-low advanced or metastatic breast cancer in England, having previously rejected it on cost-effectiveness grounds. Revised pricing arrangements and changes to NICE’s assessment methods helped secure NHS access for around 1,000 eligible patients.

The decision concerns a different indication from Enhertu’s latest EU approval, but shows how pricing and reimbursement can affect access even for established treatments.

Visiongain Insight

Earlier use of ADCs could change which treatments patients receive later. Evidence on how best to sequence these drugs remains limited, making it harder to predict demand as new indications gain approval.

Forecasts that treat every new indication as an entirely separate source of revenue risk overstating growth, particularly where patient populations and treatment pathways overlap.

From Visiongain

Visiongain’s ADC research examines the market from drug development and competitive positioning through to specialist manufacturing and commercial supply.

• Antibody Drug Conjugates Market Report 2026–2036: Product and regional forecasts, target antigens, payload technologies and competitive analysis.
• Antibody Drug Conjugates Contract Manufacturing Market Report 2026–2036: Manufacturing services, specialist capabilities, outsourcing demand and market forecasts.

Both reports provide detailed market intelligence to support investment, business development and expansion decisions.

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