In-Depth Analysis of Hengrui Medicine's Multi-Cancer Indication Layout Strategy for HER2 ADC

Based on the above in-depth research data, I now provide you with a comprehensive analysis report on Hengrui Medicine’s multi-cancer indication layout strategy in the HER2 ADC track.

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Hengrui Medicine’s self-developed HER2 ADC drug, Ruikang Trastuzumab (SHR-A1811), was approved for marketing in China in

for the indication of monotherapy for previously treated patients with HER2-mutated advanced non-small cell lung cancer (NSCLC), becoming [1][2].

This milestone marks a significant strategic breakthrough for Hengrui Medicine in the HER2 ADC track.

SHR-A1811 has undergone significant differentiated optimization in its molecular structure[1]:

Feature	SHR-A1811	Enhertu (DS-8201)
Payload	Topoisomerase I inhibitor	Topoisomerase I inhibitor
Drug-Antibody Ratio (DAR)	6	~8
Linker Technology	Chiral cyclopropyl technology (enhanced stability)	Cleavable linker
Therapeutic Window	Wider	Relatively narrow

This design aims to

. Data shows that its incidence of interstitial lung disease (ILD) is 8.5% (1.1% for grade ≥3), and the discontinuation rate due to drug-related adverse events is 2.1%[1].

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As the “elder statesman” in China’s innovative drug sector, Hengrui Medicine’s R&D strategy in the HER2 ADC track is highly recognizable –

[2].

The underlying logic of this strategy is:

• Avoid Enhertu’s edge
  : Enhertu has built strong market barriers in the field of HER2-positive breast cancer
• Seize niche markets
  : Establish first-mover advantages in indications where Enhertu has not yet deeply penetrated
• Diversify risks
  : Do not rely on a single indication, and build diversified revenue sources

To date, SHR-A1811 has accumulated

, covering multiple solid tumor areas[2]:

Cancer Type	Indication Phase	Urgency of Clinical Demand
Non-Small Cell Lung Cancer (NSCLC)	Approved for marketing	High
HER2+ Breast Cancer	NDA accepted / Under priority review	High
HER2-Low Expressing Breast Cancer	Prospective layout in progress	High
Colorectal Cancer	Granted breakthrough therapy designation	High
Gastric Cancer	In clinical development	High
Biliary Tract Cancer	Granted breakthrough therapy designation	High
Ovarian Cancer	Granted breakthrough therapy designation	High
Cervical Cancer	Granted breakthrough therapy designation	Medium
Breast Cancer Neoadjuvant Therapy	Prospective layout in progress	Medium

Notable differentiated indications include[2]:

• “HER2-positive colorectal cancer that has failed prior treatment with oxaliplatin and fluorouracil”
• “Platinum-resistant recurrent HER2-expressing ovarian cancer”

Hengrui Medicine is advancing the R&D of a

[3]:

• November 2025
  : Registered for Phase I trial of the subcutaneous injection version
• Planned enrollment
  : 107 patients with advanced solid tumors
• Dose groups
  : Three dose groups of 4.8, 6.4, 8.0 mg/kg
• Head-to-head comparison
  : Compared with the 4.8 mg/kg intravenous version
• Primary endpoint
  : PK and safety 21 days after administration

: If successful, it will reduce the single infusion time from 1-2 hours to a few minutes, opening up possibilities for outpatient and home-based treatment.

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SHR-A1811 demonstrated excellent efficacy in previously treated patients with HER2-mutated advanced NSCLC[1]:

Index	Data
Objective Response Rate (ORR)	74.5%
Confirmed Objective Response Rate (cORR)	58.3%
Disease Control Rate (DCR)	91.7%
ORR in Patients with Baseline Brain Metastases	87.5%

: For patients with baseline brain metastases, subgroup analysis showed an ORR of 87.5%, confirming the clinical potential of ADC drugs in central nervous system (CNS) control.

Although Hengrui Medicine’s layout in the breast cancer track is “not considered a ‘heavy punch’”, its layout strategy is steady[2]:

Indication	Development Stage	Status
HER2+ Breast Cancer Second-Line Therapy	NDA accepted	Under priority review procedure
HER2+ Breast Cancer Neoadjuvant Therapy	Clinical exploration	Prospective layout
HER2-Low Expressing Breast Cancer	Clinical exploration	Prospective layout

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Enhertu, co-developed by Daiichi Sankyo/AstraZeneca, has evolved into a “complete form”[2]:

Achievement	Details
Breast Cancer First-Line Therapy	Approved in combination with pertuzumab
Adjuvant Therapy	Positive results from Phase III studies such as DESTINY-Breast05
Neoadjuvant Therapy	Actively being pursued
Approved Indications	Covers breast cancer, gastric cancer, lung cancer, gastroesophageal junction cancer, colorectal cancer

: As Enhertu continues to “narrow the circle” to earlier-line indications, the HER2 ADC breast cancer track is approaching the final round, and the industry is very likely to enter a stage of fierce elimination[2].

Company	Core Product	Strategic Positioning	Differentiated Advantage
Hengrui Medicine	SHR-A1811	“Rural Surrounding Cities” across multi-cancer indications	9 breakthrough therapy designations, strong clinical execution capabilities
Kelun Biotech	A166 (Bodu Trastuzumab)	Following in Enhertu’s footsteps	First domestic ADC approved for HER2+ breast cancer second-line therapy; mPFS 11.1 months vs T-DM1 4.4 months
RemeGen	Vidutolimab (RC48)	“Tianji’s Horse Racing”	First-mover advantages in gastric cancer and urothelial cancer; $2.6 billion licensing deal with Seagen
Betalab Therapeutics	T-Bren (BL-M07D1)	Directly competing with Enhertu	NSCLC ORR 62%, 6-month DoR rate 95.7%; aggressive global layout

                    Degree of Differentiation
                    Low          High
              ┌─────────────────────────────────┐
       Mainstream │   Kelun Biotech    │   Betalab Therapeutics   │
    Market       │ (Breast Cancer 2L) │ (Breast Cancer 1L)       │
  Competition    │                     │                         │
   Intensity     ├─────────────────────┼─────────────────────────┤
       Niche     │   Hengrui Medicine  │   RemeGen               │
       Market    │ (Multi-Cancer Layout)│ (Gastric/Urothelial Cancer) │
              └─────────────────────┴─────────────────────────┘

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Hengrui Medicine and RemeGen have “quite similar layout ideas, both focusing on the differentiated path of ‘avoiding Enhertu’s edge and seizing niche indications’. However, the core gap between them lies in clinical execution capabilities” – as a leading enterprise deeply engaged in innovative drugs for many years, Hengrui Medicine has advantages in[2]:

• Clinical trial advancement efficiency
• Standardization of data disclosure
• Commercialization capabilities

that have been verified by the industry, significantly outperforming peers such as RemeGen.

“Perhaps SHR-A1811 is not currently the ‘most competitive single-point product’ in the HER2 ADC track, but relying on the breadth of its multi-cancer indication layout, the speed of clinical advancement, and Hengrui Medicine’s commercialization capabilities, this drug has become an unignorable core force in the HER2 ADC industry”[2].

• Sales network: Although streamlined to about 10,000 people, it remains
  the most powerful commercialization team in China
  [4]
• Coverage capability: Can quickly cover thousands of grade hospitals across the country
• Medical insurance negotiation capability: Multiple innovative drugs including SHR-A1811 were successfully included in medical insurance in 2024

Hengrui Medicine’s modular ADC innovation platform (HRMAP), built over more than a decade of accumulation, demonstrates strong engineering capabilities[4]. This

can:

• Support rapid iteration of multiple ADC drug candidates
• Ensure quality consistency in manufacturing
• Provide technical endorsement for international cooperation under the NewCo model

As Enhertu extends to areas such as adjuvant therapy and neoadjuvant therapy, it may further compress the market space of domestic ADCs[2].

In core indications such as breast cancer, SHR-A1811 may need to conduct head-to-head comparisons with Enhertu in the future. If it fails to show significant advantages, it will affect peak sales forecasts[4].

If the medical insurance reimbursement standard is significantly reduced in the future, or if unfavorable changes occur in the simplified renewal rules for innovative drugs, it will compress the product’s life cycle value[4].

Hengrui Medicine adopts the NewCo model to promote internationalization, relying on the advancement efficiency of partners. If partners encounter problems in financing or clinical operations, it will directly affect milestone revenue[4].

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Time Period	Return
1 Year	+50.71%
6 Months	+13.39%
3 Months	-3.67%
YTD	+2.28%

As of January 13, 2026, Hengrui Medicine’s stock price is

, with a market capitalization of , and a PE multiple of approximately [0].

Index	Value	Industry Status
ROE	14.19%	Healthy
Net Profit Margin	24.10%	Excellent
Operating Profit Margin	27.72%	Excellent
Current Ratio	6.55	Extremely strong liquidity
Debt Risk	Low	Financially sound[0]

The market’s valuation of Hengrui is shifting from

[4]:

• Traditional business
  : Given a PE multiple of 15-20x for generics and mature innovative drugs
• Innovative pipeline
  : For assets in late-stage clinical development with verified commercial value such as SHR-A1811, independent valuation should be given with reference to the DCF model
• Cash and equity
  : Equity held by NewCo and book cash should be added back separately

As the proportion of innovative drug revenue increases, Hengrui’s reasonable PE multiple is expected to recover from 20-30x at the bottom of volume-based procurement to

[4].

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1. Accelerate approval of breast cancer second-line therapy
   : Ensure SHR-A1811 is approved as soon as possible for the indication of HER2+ breast cancer second-line therapy
2. Deepen penetration of lung cancer market
   : As the first domestic HER2 ADC approved for this indication, quickly establish market position
3. Promote medical insurance negotiation
   : Strive to include more indications in medical insurance in the next medical insurance negotiation cycle

1. Expand multi-cancer indications
   : Complete NDA for key indications such as colorectal cancer, gastric cancer, and biliary tract cancer
2. Commercialize subcutaneous injection formulation
   : If approved, it will significantly improve patient compliance and market competitiveness
3. Internationalization implementation
   : Achieve overseas commercialization of core products through the NewCo model

1. Develop combination therapies
   : Explore the potential of combined application with PD-1/PD-L1 inhibitors
2. Layout drug-resistant scenarios
   : Conduct prospective layout for treatment needs after drug resistance to mainstream drugs such as Enhertu
3. Iterate next-generation ADC platform
   : Continuously launch more competitive next-generation products relying on the HRMAP platform

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Hengrui Medicine’s multi-cancer indication layout strategy in the HER2 ADC track

, mainly reflected in the following aspects:

Competitive Advantage Dimension	Evaluation
Strategic Differentiation	★★★★☆ Avoids Enhertu’s edge and establishes first-mover advantages in niche markets
Clinical Execution Capabilities	★★★★★ Leading clinical operation capabilities among leading enterprises in the industry
Commercialization Capability	★★★★★ Supported by the most powerful commercialization team in China to drive product scaling
Platform Capability	★★★★☆ HRMAP platform provides continuous innovation momentum
International Layout	★★★★☆ NewCo model avoids risks while achieving global expansion
Financial Soundness	★★★★★ Low debt risk, strong cash flow supports R&D investment

: Hengrui Medicine’s multi-cancer indication layout strategy for HER2 ADC reflects the strategic wisdom of “Rural Surrounding Cities”. Although its single-point competitiveness may not match the aggressive strategies of enterprises such as Betalab Therapeutics, relying on , SHR-A1811 is expected to become an unignorable core force in the HER2 ADC industry.

This strategy is particularly suitable for industry leaders with systematic advantages like Hengrui Medicine –

, and has the strongest ability to navigate cycles amid the capital winter[4].

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[1] Liangyihui - “From ‘Raw Stone’ to Clinical Cornerstone: Target Deepening and Treatment Pattern Remodeling of ADC Drugs for Lung Cancer” (http://www.liangyihui.net/doc/161398)

[2] 36Kr - “HER2 ADC Narrowing the Circle: Live or Die for Domestic Players?” (https://www.36kr.com/p/3635886719960325)

[3] Drugtimes - “Betalab Therapeutics, Hengrui, Zhengda Tianqing Simultaneously Advance HER2 ADC Innovative Drugs!” (https://www.drugtimes.cn/kuaixun/)

[4] PharnexCloud - “In-Depth Research Report on Hengrui Medicine: Leading Innovative Drugs, ADC, Chronic Diseases, and Overseas Expansion Engine” (https://www.pharnexcloud.com/zixun/sd_266131)

[0] Jinling API Market Data