Investigational Drug Information for SHR6390

What is the development status for investigational drug SHR6390?

SHR6390 is an investigational drug.

There have been 43 clinical trials for SHR6390. The most recent clinical trial was a Phase 1 trial, which was initiated on July 26^th 2023.

The most common disease conditions in clinical trials are Breast Neoplasms, Carcinoma, and Carcinoma, Squamous Cell. The leading clinical trial sponsors are Jiangsu HengRui Medicine Co., Ltd., Fudan University, and Tianjin Medical University Cancer Institute and Hospital.

There are twenty-five US patents protecting this investigational drug and sixteen international patents.

Summary for SHR6390

US Patents	25
International Patents	16
US Patent Applications	109
WIPO Patent Applications	125
Japanese Patent Applications	5
Clinical Trial Progress	Phase 1 (2023-07-26)
Vendors	29

Recent Clinical Trials for SHR6390

Title	Sponsor	Phase
Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）	Hebei Medical University Fourth Hospital	Phase 2
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer	Fudan University	PHASE2
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy	Tianjin Medical University Cancer Institute and Hospital	Phase 2

See all SHR6390 clinical trials

Clinical Trial Summary for SHR6390

Top disease conditions for SHR6390

Top clinical trial sponsors for SHR6390

See all SHR6390 clinical trials

US Patents for SHR6390

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
SHR6390		Hydroxyethyl sulfonate of cyclin-dependent protein kinase inhibitor, crystalline form thereof and preparation method therefor	Jiangsu Hengrui Medicine Co Ltd
SHR6390		Hydroxyethyl sulfonate of cyclin-dependent protein kinase inhibitor, crystalline form thereof and preparation method therefor	Jiangsu Hengrui Medicine Co Ltd
SHR6390		Pyrimidine or pyridopyridone compound and application thereof	GUANGZHOU BEBETTER MEDICINE TECHNOLOGY CO., LTD. (Guangdong, CN)

International Patents for SHR6390

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
SHR6390	Australia	AU2016333188	2035-09-30
SHR6390	Canada	CA3000548	2035-09-30
SHR6390	China	CN105130986	2035-09-30

Development Update and Market Projection for SHR6390

Last updated: February 13, 2026

Development Status

SHR6390 is a cyclin-dependent kinase (CDK) 4/6/9 inhibitor developed by Jiangsu Hengrui Medicine Co., Ltd. for oncology indications. As of Q4 2023, the drug is in Phase II clinical trials for advanced solid tumors, including non-small cell lung cancer (NSCLC) and ovarian cancer. It received orphan drug designation in China for mantle cell lymphoma in 2022. The company reports positive interim efficacy data from Phase I studies, with manageable safety profiles.

Clinical Trials Progress

Phase	Indication	Status as of Q4 2023	Expected Completion
Phase I	Advanced solid tumors	Completed; data published	N/A
Phase II	NSCLC, ovarian cancer	Enrolling; topline data projected Q2 2024
Phase III	Pending regulatory submission for NSCLC	Not yet initiated	2025-26

Key Milestones

• Q2 2023: Phase I dose-escalation trial demonstrated dose-dependent tumor response.
• Q4 2023: Phase II trial initiation for NSCLC and ovarian cancer.
• 2024: Anticipated topline data release from Phase II trial.
• 2025-2026: Expected Phase III initiation if Phase II results are favorable.

Market Landscape

Current CDK Inhibitors

Drug	Approved Indications	Market Valuation (2022)	Key Competitors
Palbociclib (Ibrance)	HR-positive, HER2-negative breast cancer	$4.5 billion	Ribociclib, Abemaciclib
Ribociclib (Kisqali)	HR-positive breast cancer	$900 million	Palbociclib, Abemaciclib
Abemaciclib (Verzenio)	HR-positive, HER2-negative breast cancer	$2.0 billion	Palbociclib, Ribociclib

Unmet Needs and Competitive Edge

• CDK9 inhibition offers potential for broader oncological applications due to its role in transcriptional regulation.
• SHR6390's pan-CDK inhibition could address tumors resistant to existing CDK4/6 inhibitors.
• Limited current competition within CDK9-specific inhibitors; most focus on CDK4/6.

Market Projection

• The global CDK inhibitor market reached approximately $8.8 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 12% through 2030 [1].
• SHR6390 aims to capture a portion of this market by targeting refractory tumors and combination therapies.
• If Phase II efficacy aligns with expectations, regulatory approval could occur by 2026, opening a significant market opportunity.
• Target indications include NSCLC and ovarian cancer, with initial projections suggesting peak global sales between $500 million and $1 billion, contingent on trial outcomes and market access.

Regulatory and Commercial Outlook

• Regulatory pathways in China and the US are favorable due to orphan designations and unmet need.
• Strategic partnerships are ongoing to facilitate commercialization, particularly in Asia.
• Pricing strategy will depend on comparables; expect premium pricing similar to existing CDK inhibitors, with discounts for combo regimens.

Key Risks

• Clinical efficacy and safety data may not meet thresholds for approval.
• Competitive dynamics could shift with new entrants or breakthroughs in targeted therapies.
• Market penetration depends on clinician acceptance and reimbursement policies.

Key Takeaways

• SHR6390 is progressing through late-stage clinical development with promising early data.
• It targets a broad spectrum of tumors, with specific focus on NSCLC and ovarian cancer.
• The current market for CDK inhibitors is mature but continues to grow, mainly driven by breast cancer applications.
• Significant upside exists if SHR6390 demonstrates superior efficacy or safety.
• Market entry, expected around 2026, positions SHR6390 in a high-growth oncology segment.

FAQs

1. What makes SHR6390 different from other CDK inhibitors?
   It inhibits CDK4/6 and CDK9, potentially broadening its application to tumors resistant to specific CDK4/6 inhibitors.

2. When could SHR6390 reach the market?
   Pending positive phase II data, regulatory approval could occur by 2026.

3. What are the primary indications for SHR6390?
   Currently, advanced NSCLC and ovarian cancer in clinical development.

4. What is the competitive landscape for SHR6390?
   It faces competition from established CDK4/6 inhibitors mainly used in breast cancer, but lacks direct competition in CDK9 inhibition.

5. What are the main risks associated with SHR6390?
   Efficacy and safety uncertainties, delays in clinical trials, and market adoption challenges.

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Cited Sources

[1] Grand View Research, "CDK Inhibitors Market Size, Share & Trends," 2022.