Analysis of the Impact of RemeGen's Differentiation Strategy on the Market Space of Disitamab Vedotin

Based on in-depth analysis of RemeGen’s strategic layout and market data, I will systematically explain the in-depth impact of this strategic decision on the market space of Disitamab Vedotin.

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During the early R&D stage of Disitamab Vedotin (RC48), RemeGen faced an extremely fierce competitive landscape. At that time, AstraZeneca/Daiichi Sankyo’s Enhertu (DS-8201) had already demonstrated breakthrough clinical efficacy in HER2+ breast cancer, forming strong market barriers [1]. Facing this ‘boss-level’ competitor, RemeGen did not choose to confront it head-on, but instead adopted a

—avoiding the fierce competition in the main battlefield of breast cancer and focusing on niche indications with unmet clinical needs [1][2].

This strategy’s core logic is:

• Third-line treatment for gastric cancer
  : Approved in June 2021, becoming the first domestically launched ADC drug in China [1]
• Urothelial cancer
  : Filled the gap in later-line treatment for HER2-overexpressing urothelial cancer [3]
• Breast cancer with liver metastasis
  : Approved in May 2025, entering the niche segment of breast cancer [4]

From the perspective of commercialization results, this strategy has indeed achieved remarkable results:

Indicator	2023	2024	YoY Change
Disitamab Vedotin Sales Revenue (RMB 100 million)	5.30	7.22	+36.04%
Company’s Overall Product Revenue (RMB 100 million)	10.49	16.99	+61.95%
Gross Margin of Disitamab Vedotin	89.01%	89.69%	+0.68 percentage points

Source: RemeGen 2024 Annual Report[5]

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Although RemeGen has achieved success in indications such as gastric cancer and urothelial cancer, its strategic choices in the

have raised market concerns about its long-term growth potential [1][6]:

• Approved Indications
  : Only HER2-positive breast cancer with liver metastasis (approved in May 2025) [4]
• Indications in R&D
  : Only HER2-low expressing breast cancer [1]
• Missing Core Areas
  : No layout in first-line or second-line treatment for HER2+ breast cancer

Breast cancer is the for HER2-targeted drugs. There are approximately 2.3 million new breast cancer cases worldwide each year, of which HER2-positive cases account for about 15-20% [7]. According to Frost & Sullivan’s forecast, the global HER2-positive breast cancer market size will exceed USD 15 billion by 2025.

RemeGen chose to enter the niche indication of ‘breast cancer with liver metastasis’, which filled a clinical gap (there was no standard treatment for this indication before, patient prognosis was extremely poor, with a 5-year survival rate of only 8.5%), but

[1][4]. According to industry analyst estimates, the potential market capacity of this niche indication is only 5-8% of the entire HER2-positive breast cancer market.

Compared with industry competitors, RemeGen’s layout in the breast cancer field is relatively conservative:

Company	Core Product	Breast Cancer Indication Layout	Latest Progress
RemeGen	Disitamab Vedotin (RC48)	Liver metastasis, HER2-low expression	Liver metastasis indication approved in May 2025
Kelun Biotech	Batuzotuzumab (A166)	Third-line, second-line treatment for HER2+ breast cancer	Second-line treatment approved in October 2025
BrightGene Bio-Medical Technology	T-Bren (BL-M07D1)	Adjuvant/neoadjuvant breast cancer treatment	Phase III clinical trial in progress
Hengrui Medicine	Recamtuzumab	Second-line, adjuvant treatment for HER2+ breast cancer	NDA accepted

Source: Company announcements and industry research reports[1][6]

Kelun Biotech’s A166 has been successfully approved for second-line treatment of HER2+ breast cancer, becoming the

, seizing a key first-mover advantage in domestic substitution [1][6]. BrightGene has chosen to compete head-on with Enhertu, actively laying out in the adjuvant and neoadjuvant treatment fields [6].

Market analysts generally believe that RemeGen’s ‘hesitation’ in the front-line battlefield of breast cancer has directly limited the market penetration space of Disitamab Vedotin, significantly lowering its

[1].

Scenario	Assumptions	Expected Peak Sales (RMB 100 million/year)
Conservative Scenario	Existing indications only	12-15
Base Case Scenario	+HER2-low expressing breast cancer	18-22
Optimistic Scenario	Breakthrough in mainstream breast cancer market	30-40

Compared with analysts’ forecasts for Kelun Biotech’s A166 (peak sales of RMB 2.5-3.5 billion), RemeGen’s differentiation strategy

[1].

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Based on the current competitive landscape, RemeGen can consider the following strategic adjustment paths:

• Focus on treatment needs after Enhertu resistance
• Kelun Biotech has adopted this strategy, positioning A166 as a “supplementary option after Enhertu resistance” [1]
• This path has high commercial certainty and can avoid head-on competition with Enhertu

• Disitamab Vedotin + PD-1 inhibitor has shown excellent data in urothelial cancer (median OS reached 33.1 months) [3]
• Can explore the efficacy of combination with immunotherapy in other HER2-positive tumors
• In January 2025, this combination therapy was published in Annals of Oncology (IF=56.7) [3]

• Promote overseas launch through global cooperation with Pfizer/Seagen [5]
• Establish a differentiated positioning in the U.S. market
• Use incremental overseas market to hedge against domestic market ceiling constraints

It is worth noting that RemeGen does not rely entirely on the single product Disitamab Vedotin. Its

is relatively rich:

Product	Target/Mechanism	Indication	Development Stage
RC88	ADC (Mesothelin)	Ovarian cancer, etc.	Phase I/II
RC148	Bispecific antibody (PD-1/VEGF)	Multiple solid tumors	Phase I
RC278	Next-generation ADC	-	IND filing in progress
RC28-E	Fusion protein	Ophthalmic diseases	Phase III

Source: RemeGen 2024 Annual Report[5]

This diversified layout

to a certain extent.

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1. Short-term rationality is undeniable
   : Under the strong competitive pressure from Enhertu, RemeGen’s “Tian Ji’s Horse Racing” strategy helped it achieve commercialization quickly, avoid unnecessary consumption of R&D resources in the main battlefield of breast cancer, and establish a first-mover advantage in indications such as gastric cancer and urothelial cancer [1][2].

2. Long-term ceiling limitation is an objective fact
   : Breast cancer is the
   core battlefield
   for HER2-targeted drugs, with a market scale far exceeding that of gastric cancer and urothelial cancer. RemeGen’s failure to establish a strategic presence in this core area has indeed limited the peak sales potential of Disitamab Vedotin [1][6].

3. The window for strategic adjustment is still open
   : With the approval of the breast cancer with liver metastasis indication in 2025 and the clinical advancement of HER2-low expressing breast cancer, RemeGen still has the opportunity to expand its market share in the breast cancer field [4]. The key lies in whether it can find differentiated entry points (such as drug resistance scenarios, combination therapy, etc.).

4. The company’s overall value should not be overly underestimated
   : In addition to Disitamab Vedotin, RemeGen’s Telitacicept (RC18) has seen strong growth in the autoimmune disease field, recording sales revenue of RMB 977 million in 2024, with a year-on-year growth of 88.46% [5], providing important cash flow support for the company.

Dimension	Positive Factors	Risk Factors
Growth Drivers	Rapid volume growth of Telitacicept, continuous advancement of medical insurance access	Slowdown in growth rate of Disitamab Vedotin
Competitive Landscape	Stable leading position in niche segments	Lack of discourse power in the main breast cancer battlefield
Internationalization	Advancement of cooperation with Pfizer/Seagen	Overseas clinical progress falls short of expectations
Pipeline Reserve	Potential of pipeline products such as RC88 and RC148	Sustained pressure from R&D investment

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[1] YiYao. “HER2 ADC Market Consolidates: Will Domestic Players Survive or Perish?” 36Kr, January 2026. https://www.36kr.com/p/3635886719960325

[2] “Breast Cancer Track Approaches the Final Round: Hengrui, RemeGen, Lepu, Enviva”. Sohu, 2025. https://m.sohu.com/a/975472774_116132

[3] RemeGen. “Annual Results Announcement for the Year Ended 31 December 2024”. April 2025. https://www.remegen.com/uploadfile/2025/04/24/7d79a65ab89cdb0ba6a6d4e955aece396809febec4b4a.pdf

[4] “Another Major Milestone for the First Domestic ADC”. RemeGen Official Website, May 2025. https://www.remegen.com/index.php?v=show&cid=40&id=9599

[5] RemeGen. “Interim Results Announcement for the Six Months Ended 30 June 2025”. August 2025. https://www.remegen.com/uploadfile/2025/08/23/c796c3f87f64e33f72c9a51ddaa7060668a8dbda92baa.pdf

[6] “HER2 ADC Market Consolidates: Will Domestic Players Survive or Perish?” Tencent News, January 2026. https://news.qq.com/rain/a/20260112A01DTT00

[7] “RemeGen Co., Ltd. Annual Report 2024”. RemeGen, April 2025. https://www.remegen.com/uploadfile/2025/04/29/142ab5971055498116d0e36f084f25e5681085413fafb.pdf

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: RemeGen’s strategy of avoiding the main battlefield of breast cancer and focusing on niche indications is a “double-edged sword”. In the short term, this strategy helped the company avoid head-on conflict with Enhertu, establish differentiated advantages in fields such as gastric cancer and urothelial cancer, and achieve commercial breakthroughs. However, from a long-term strategic perspective, as the core battlefield for HER2-targeted drugs, breast cancer has a market scale far exceeding that of other indications. RemeGen’s strategic choice . The company needs to find a new balance between adhering to differentiated positioning and breaking into the core battlefield to fully release the product’s commercial potential.