SPSun Pharmaceutical Industries524715New partnership deal

Exclusive global licensing deal with LIB Therapeutics for PCSK9 inhibitor lerodalcibep, ex-US and China

Sun Pharma has signed an exclusive licensing agreement with LIB Therapeutics to commercialize and manufacture lerodalcibep worldwide, excluding the US and China.

By ScoutQuest · Mon 28 Sep 2026, 8:20 AM IST · 2 min read

Product

Lerodalcibep (Lyrokaul) - once-monthly PCSK9 inhibitor injection

EU Approval Date

September 21, 2026

Licensed Territory

Worldwide excluding US and China

Target Market Size

US$3.7 billion PCSK9 market ex-US and China, growing at 38% CAGR

European Market

US$2.9 billion in MAT Q2 2026

What was announced

Sun Pharma and US-based LIB Therapeutics Inc. announced an exclusive licensing agreement under which Sun gets rights to commercialize and manufacture lerodalcibep worldwide, excluding the United States and China (China here covers mainland China, Hong Kong, Macau and Taiwan). A few other territories, limited in number, will be covered through separate agreements between Sun and LIB.

The product

• Lerodalcibep is a PCSK9 inhibitor that lowers LDL-C, often called "bad" cholesterol.
• Dosing is a once-monthly 300 mg/1.2 mL subcutaneous injection.
• The EU label allows storage at room temperature up to 25°C for up to six months after removal from refrigeration.
• It received EU approval on September 21, 2026 under the brand name Lyrokaul, for adults with primary hypercholesterolaemia (including HeFH) or mixed dyslipidaemia, as an adjunct to diet.
• In the US it is FDA-approved under the brand name Lerochol.

Commercial terms

LIB will receive an upfront payment and future milestone payments, plus royalties based on net sales in the licensed territories. Other terms of the agreement are confidential. Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained.

Market context cited

• PCSK9 inhibitor market outside the US and China: US$ 3.7 billion (MAT Q2 2026, IQVIA), growing at a 38% CAGR over the preceding two years.
• Europe alone: US$ 2.9 billion in MAT Q2 2026.
• Global PCSK9 market approaching US$7 billion in 2026.
• In the DA VINCI study across 18 European countries, only 33% of patients on stable oral lipid-lowering therapy reached their risk-based LDL-C goals, which the companies cite as the unmet need.

Safety profile noted in the EU label

• Injection site reactions occurred in 11.6% of patients in pivotal studies.
• Most frequent: injection site reaction 6.7%, erythema 3.6%, bruising 1.6%, pruritis 1.0%.
• Discontinuation due to injection site reactions: 1.0%; severe reactions 0.2%.

How investors may read it

The deal adds a cardiovascular asset to Sun's Innovative Medicines portfolio, which the company says accounts for about 22% of company sales. Revenue will depend on launch timing, pricing and further regulatory approvals across the licensed markets; the size of the upfront and milestone payouts is confidential.

Nothing here is a view, opinion or recommendation of ScoutQuest, its parent, directors or employees. ScoutQuest is a technology company: this page was assembled automatically from public sources using artificial intelligence, and may contain errors or omissions. Confirm everything against the original source before you act on it. Any use of this page is at your own risk, and neither ScoutQuest nor its parent, directors or employees accepts liability for it.

About ScoutQuest · Logos provided by Logo.dev