In-Depth Analysis of the Commercialization Prospects for Hengrui Medicine's FIC/BIC Pipeline

Based on collected data and market information, I provide you with a systematic analysis of the commercialization prospects for Hengrui Medicine (SH600276)'s FIC/BIC pipeline.

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As China’s largest pharmaceutical company by market capitalization (approximately $39 billion), Hengrui Medicine has established an innovative drug R&D system covering four core therapeutic areas: oncology, cardiovascular and metabolism, immunology and respiratory, and neuroscience. As of 2025, the company is conducting over 400 clinical trials for more than 100 new molecular entities (NMEs), has commercialized 23 innovative drugs, and its pipeline scale ranks among the top globally [0][1].

Phase	Quantity	Representative Products
Commercialized	23	Camrelizumab, Dalpiciclib, Fluzoparib, etc.
NDA/BLA Accepted	5	HRS9531, Emaxitinib, etc.
Phase III Clinical	10	HRS-4642, HRS9531, Ruikang Trastuzumab ADC, etc.
Phase II Clinical	22	Multiple early-stage FIC/BIC assets
Phase I Clinical	15	Next-generation ADC, PROTAC, etc.

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• Submitted NDA application in September 2025, expected to be approved for marketing in 2026 [2][3]
• Phase III clinical trial (n=567) showed that after 48 weeks of treatment with the 6mg dose group, the average weight loss reached
  19.2%
  , which is significantly better than the placebo
• 44.4% of subjects achieved weight loss ≥20%, approaching the effect of metabolic surgery
• Favorable safety profile, no new safety signals identified [3]

• Leading Domestic Progress
  : The first domestically developed GLP-1/GIP dual-agonist to submit a marketing application, directly benchmarked against Eli Lilly’s Tirzepatide (20.9% weight loss)
• Licensing Deal
  : Licensed to Kailera Therapeutics for $6 billion in 2024 (Hengrui holds 19.9% stake), validating its international value
• Market Size
  : The global weight loss drug market is expected to reach $150 billion by 2035, with enormous potential in the Chinese market
• Pricing Strategy
  : Industry insiders predict it will not engage in excessive price wars, and is more likely to achieve volume growth through national health insurance negotiations [4]

• The world’s first KRAS G12D inhibitor to enter Phase III clinical trials
  , achieving a breakthrough in an “undruggable” target [1][5]
• Phase Ib/II clinical trial for first-line treatment of pancreatic cancer: ORR reached
  63.3%
  , with excellent data
• Received breakthrough therapy designation from CDE in 2025

• Pancreatic cancer is one of the most malignant tumors, with limited existing treatment options and huge unmet clinical demand
• KRAS G12D mutations are common in pancreatic cancer and colorectal cancer, representing a substantial patient population
• As an FIC product, it is expected to receive priority review and accelerated approval pathways

• Phase III clinical trials ongoing for breast cancer, gastric cancer, lung cancer, etc.
• Superior safety profile compared to competitor DS-8201 (lower incidence of interstitial pneumonia)
• Received breakthrough therapy designation from the FDA

• The HER2-positive cancer market is enormous (including breast cancer, gastric cancer, etc.)
• Differentiated safety advantages support long-term medication use
• Continuous iteration of the ADC technology platform ensures sustained competitiveness

Product	Target/Mechanism	Indication	Progress	Commercialization Prospects
Fluzoparib	PARP1/2	Ovarian cancer, Prostate cancer	Phase III	Growing demand for precision therapy
Dalpiciclib	CDK4/6	Adjuvant treatment of breast cancer	Phase III (primary endpoint achieved)	HR+/HER2- breast cancer market
HRS-5346	Lp(a) inhibitor	Hyperlipidemia	Phase I	Licensed to Merck with a €200 million upfront payment
HRS-7535	Oral GLP-1	Type 2 diabetes	Phase II	Advantage of oral administration convenience

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• 10 new products were included in the National Health Insurance Catalog in 2025
• Innovative drug revenue accounts for 55.3% of total pharmaceutical revenue, with a year-on-year increase of 23.1% [0][1]
• 2026 Target: Innovative drug revenue to grow by over 25% year-on-year

• Nationwide specialized sales team
• Rich commercialization experience in oncology, metabolism, and other therapeutic areas
• Innovative drug sales revenue reached approximately RMB 15.8 billion in 2025

• Boston R&D Center officially launched in 2025
• Established 15 global R&D centers with an R&D team of over 5,600 employees
• Listed on the Hong Kong Stock Exchange, raising approximately $1.5 billion to optimize global capital management

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Since 2023, Hengrui has completed

with a total transaction value of , key collaborations include:

Partner	Project	Transaction Value
GSK	Strategic alliance for 6 projects	~$12 billion (largest single deal)
Merck KGaA	Lp(a) inhibitor, etc.	$2 billion
MSD	12 innovative projects	Up to $1.2 billion
Kailera	GLP-1/GIP (HRS9531)	$6 billion (NewCo model)

These collaborations have validated the international value of Hengrui’s FIC/BIC pipeline and provided financial and experiential support for subsequent commercialization.

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Timeframe	Milestone Event
Early 2026	Expected approval and launch of HRS9531
H1 2026	Approval of >10 innovative drugs/indications
Full Year 2026	Submission of over 20 NDA/BLA applications
Full Year 2026	Data readout from 25 Phase III studies
2026	Preparation for multiple overseas new drug marketing applications

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• GLP-1 field: Novo Nordisk and Eli Lilly continue to cut prices, and domestic semaglutide biosimilars are about to be launched [4]
• ADC field: Multiple domestic and international companies are developing products targeting the same targets

• Price reduction pressure from national health insurance negotiations
• Uncertainty in innovative drug pricing policies

• Risk of clinical trial failure
• Regulatory approval uncertainty

• Relatively limited overseas clinical and commercialization experience
• Geopolitical factors may affect collaborations

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✅ Balanced pipeline depth and quality, with a dense portfolio of FIC/BIC assets
✅ Mature commercialization capabilities and strong national health insurance access capabilities
✅ Innovative value validated through BD collaborations, with a clear globalization path
✅ Strong platform-based R&D capabilities, with promising sustained innovation

🔹 HRS9531 approval timeline and pricing strategy
🔹 HRS-4642 Phase III clinical data readout
🔹 Impact of national health insurance negotiation results on revenue
🔹 Milestone achievement of BD collaborations

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Hengrui Medicine’s FIC/BIC pipeline is at the tipping point of commercialization explosion.

is expected to become China’s first domestically developed GLP-1/GIP dual-target weight loss drug to launch in 2026, filling a market gap; ’s breakthrough in an “undruggable” target demonstrates the company’s innovative capabilities; oncology assets such as are also in critical Phase III stages.

With 10 new products included in national health insurance, continuous increase in innovative drug revenue proportion, and deepening international BD collaborations, Hengrui Medicine is transforming from a “domestic innovative drug leader” to a “global pharmaceutical company”. 2026 will be a critical year for the commercialization realization of Hengrui’s FIC/BIC pipeline, worthy of key attention from investors.

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[0] Jinling API - Hengrui Medicine Company Overview and Financial Data

[1] NetEase Finance - “FIC/BIC Pipeline Breakthrough, BD Harvest, Hong Kong Listing! 2026, Hengrui Stands at the ‘Explosion Point’” (https://www.163.com/dy/article/KJI7RIGM051984TV.html)

[2] PharmNet - “Blockbuster! Hengrui Medicine Submits Marketing Application for GLP-1/GIP Dual-Target Weight Loss Drug” (https://www.phirda.com/artilce_40144.html)

[3] Clarivate/Industry Report - 2026 Most Watched Drug Predictions

[4] The Paper - “Weight Loss Miracle Drugs, Collective Price Cuts” (https://m.thepaper.cn/newsDetail_forward_32264551)

[5] East Money - Hengrui Medicine 2025 JPM Conference Presentation Materials