Fosun Pharma, Novartis, and Other Pharma Companies Submit New Drug Applications for Market Approval in China

　　【Pharmaceutical Network Product InformationAccording to the review, within the past month, several pharmaceutical companies have submitted applications for the market launch of innovative drugs. The companies involved include Fosun Pharmaceutical, Hansoh Pharma, LEPU BIOPHARMA, and Novartis.
 

On March 6, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the marketing application of Fosun Pharmaceutical's member company Fosun Wanbang's new drug, Succinic Acid Furanitinib Capsules, has been accepted.
 

Public information shows that SAF-189s (foritinib), developed by Fosun Pharmaceutical, is an innovative small-molecule chemical drug. It is a new-generation highly effective ALK/ROS1 inhibitor with strong central nervous system (CNS) permeability and the ability to cross the blood-brain barrier efficiently. During the 2024 World Conference on Lung Cancer (WCLC), interim analysis results of the phase 3 REMARK study on foritinib treating ALK-positive non-small cell lung cancer were disclosed as a late-breaking abstract (LBA). In this study, foritinib achieved an intracranial objective response rate (ORR) of 100% in ALK-positive advanced NSCLC patients with baseline brain metastases (vs 50% for the control drug).
 

On March 4, Hansoh Pharma announced that the second marketing authorization application for its innovative drug Inebilizumab Injection (Xinyue®) has been accepted by the National Medical Products Administration (NMPA). The product is intended for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD). Notably, this indication was included in the NMPA’s priority review and approval process on February 8, 2025, demonstrating the company's active progress in new drug development.
 

Inebilizumab is a targeted CD19 B-cell depleting antibody. The product was approved by the NMPA on March 14, 2022 for marketing in China and is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies.
 

On March 4, LEPU BIOPHARMA announced that it had resubmitted the marketing application for its self-developed EGFR-targeted ADC drug, MRG003 (Vebecotuzumab), after previously withdrawing the application for MRG003.
 

Data show that MRG003 is an ADC formed by conjugating an EGFR-targeted monoclonal antibody with the potent microtubule inhibitor payload monomethyl auristatin E (MMAE) through a valine-citrulline linker. It binds with high affinity to EGFR on the surface of tumor cells, and after internalization and cleavage by lysosomal proteases, releases the potent payload, leading to tumor cell death.
 

On February 27, the CDE website announced that the marketing application for Remibrutinib Tablets, a Class 1 new drug submitted by Novartis, has been accepted. Public information indicates that this is Novartis' investigational BTK inhibitor, remibrutinib. The product’s first target indication is the treatment of Chronic Spontaneous Urticaria (CSU). The Phase 3 clinical study for this indication has already achieved positive results, with patients experiencing improvement in their CSU symptoms after one week of remibrutinib treatment, which persisted up to 52 weeks. Notably, this marks the first time that remibrutinib has been filed for marketing worldwide.
 

Data show that Remibrutinib is an investigational, highly selective, covalently binding oral BTK inhibitor that can block the BTK cascade and inhibit histamine release, which leads to itchy wheals and swelling. When remibrutinib is used in combination with a standard dose of antihistamine, it targets two parts of the inflammatory pathway, producing a "two-pronged" effect: remibrutinib inhibits histamine release while antihistamines block histamine receptors, thereby alleviating CSU symptoms.
 

On February 19, Changchun High-Tech announced that its holding subsidiary, Jin Sai Pharmaceutical, had received the "Acceptance Notice" issued by the National Medical Products Administration. The application for the registration and market approval of the overseas-produced drug Leuprolide Injection Emulsion from Jin Sai Pharmaceutical has been accepted.
 

Data show that Leuprorelin Injection Emulsion (formerly known as "Leuprorelin Mesylate Suspension Injection" or "LMIS 50mg") is a long-acting formulation of gonadotropin-releasing hormone agonist (GnRHa). By the sustained release of leuprorelin in the body, it continuously occupies GnRH receptors, desensitizing the corresponding receptors on pituitary target cells. This subsequently inhibits the secretion of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and gonadal hormones via the pituitary-gonadal axis, used for androgen deprivation therapy (ADT) in advanced prostate cancer. Changchun High-Tech's announcement revealed that the two key clinical studies recently conducted on Leuprorelin Injection Emulsion have both reached their pre-set efficacy endpoints with good safety, confirming the clear benefits of this product in treating prostate cancer patients.
 

On February 18, according to Hengrui Medicine, the company's Atropine Sulfate Eye Drops (HR19034 Eye Drops) have been accepted by the National Medical Products Administration for drug marketing authorization application. The product is used to slow the progression of myopia in children aged 6 to 12 with equivalent spherical refractive error ranging from -0.50D to -4.00D (astigmatism ≤1.50D, anisometropia ≤1.50D).
 

It is reported that atropine sulfate ophthalmic solution, as a drug for preventing myopia, has been receiving much attention. Currently, only one product has been approved and marketed in China: the 0.01% atropine sulfate ophthalmic solution independently developed by Xingqi Eye Medicine. This product was approved in March 2024, becoming the first atropine sulfate ophthalmic solution in China to obtain the "National Medical Product Approval Number." Previously, atropine sulfate ophthalmic solution, as an in-hospital preparation, could only be sold within hospitals.
 

On February 18, the Center for Drug Evaluation under the National Medical Products Administration announced that the marketing application for a new 5.1-class drug, Leuprolide Injection Emulsion, jointly submitted by Accord BioPharma and Changchun Jin Sai Pharmaceutical, has been accepted. This medication is a 6-month pre-filled subcutaneous formulation, requiring only one subcutaneous injection every six months. It can be used directly from a pre-filled syringe without the need for mixing, offering significant practical advantages over similar products.
 

For pharmaceutical companies, the submission of new drug applications for market approval is a key step to achieving commercial profitability. In the future, as the products come to market, relevant patients will have more drug options, while the company's product pipeline will be further enriched and its market competitiveness further enhanced.
 

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