Hengrui Pharma Expands in Ophthalmology and Oncology with Multiple New Approvals in June

　　【Pharmaceutical Network Corporate News] Since 2026, Hengrui Pharma has entered a period of intensive harvest in the field of innovative drugs. For instance, in June, multiple products and new indications from Hengrui Pharma were approved by the National Medical Products Administration, covering the two major fields of ophthalmology and oncology.
 

On June 25, Hengrui Pharma disclosed in an announcement that adebelimab, developed by its subsidiary Shanghai Shengdi Pharmaceutical Co., Ltd., had received approval for a second indication in the field of lung cancer. Adebelimab was approved for market launch in February 2023, with the initial indication being first-line treatment in combination with carboplatin and etoposide for patients with extensive-stage small cell lung cancer.
 

The announcement indicates that the approved indication is for this product in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by continued monotherapy with this product as adjuvant treatment post-surgery, for the treatment of adult patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) without known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
 

On the same day, it also announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., had recently received notification from the National Medical Products Administration (NMPA) approving the market launch of the company’s product, Cyclosporine Eye Drops (IV). It is understood that Cyclosporine Eye Drops (IV) is CyclASol (a 0.1% cyclosporine A formulation), licensed from Novaliq GmbH (“Novaliq”), and developed based on the world’s first anhydrous drug delivery technology platform, EyeSol®.
 

Novaliq’s cyclosporine eye drops were approved for marketing in the United States in May 2023; in China, Shengqi Pharmaceutical’s Class 3 generic cyclosporine eye drops (II) were also approved for marketing by the National Medical Products Administration in 2020. In 2025, the global sales of similar products totaled approximately USD 2.106 billion.
 

On June 16, Hengrui Pharma announced that it had received notification from the National Medical Products Administration approving a new indication for its independently developed CDK4/6 inhibitor, dalpiciclib mesylate tablets. The approved indication is for adjuvant treatment in combination with endocrine therapy in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer at high risk of recurrence.
 

The approval of the new indication for Dalpiciclib is based on the positive results from a large, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (study code: DAWNA-A).
 

The dense wave of approvals indicates that Hengrui Pharma’s innovative drug portfolio is entering a comprehensive phase of fruition, covering multiple major disease areas such as metabolism, oncology, and ophthalmology, and featuring numerous global first-in-class or landmark domestically produced products. Notably, as Hengrui Pharma’s innovation efforts enter their harvest period, the company is also achieving continuous breakthroughs in its internationalization strategy.
 

In February 2026, the U.S. FDA accepted Hengrui Pharma’s resubmitted Biologics License Application (BLA) for camrelizumab in combination with apatinib as a first-line treatment for liver cancer, with a target review date of July 23, 2026.
 

Results from an international, multicenter Phase III clinical study demonstrated that camrelizumab combined with apatinib significantly prolonged overall survival (OS) and progression-free survival (PFS) compared with the current standard of care, sorafenib. The median OS reached 22.1 months (subsequently updated to 23.8 months). This combination therapy was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in April 2021.
 

In May 2026, Hengrui Pharma and BMS announced a global strategic collaboration to jointly advance 13 early-stage innovative projects spanning oncology, hematology, and immunology. This deal is not a traditional single-product licensing agreement, but rather a deep “strategic alliance.”
 

The agreement details reveal that the collaborative projects include four oncology and hematology programs originally developed by Hengrui Pharma, four immunology programs originally developed by BMS, and five co-development projects leveraging Hengrui Pharma’s R&D engine and diverse innovative technology platforms. BMS will obtain global rights outside Greater China for Hengrui’s programs and the co-development projects, while Hengrui will secure rights in Greater China for certain BMS programs, thereby achieving an exchange and complementarity of pipeline assets.
 

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