Feeling 52°C? Not as Hot as the Surge of Innovative Drug Approvals—Shanghai Shanhu Health Powers Ahead with Full Support!

On June 26, 2025, Alebund announced that the pivotal Phase III clinical study of its novel iron-containing oral phosphate binder AP301 capsule for the treatment of hyperphosphatemia in dialysis patients had completed database lock.

On June 20, 2025, the innovative insomnia drug **Kewei Ke®** (Daridorexant Hydrochloride Tablets), co-developed by Simcere and Switzerland's Idorsia, was approved for marketing in China.

On June 4, 2025, Hansoh Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had approved the marketing authorization application for Aumseqa (Amethine), a third-generation EGFR tyrosine kinase inhibitor (TKI), as a monotherapy for: first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations, and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

On May 29, 2025, Fosun Pharmaceutical's self-developed Class 1 new drug Luwomeitinib Mesylate Tablets was officially approved for marketing. The two indications are for the treatment of: Langerhans Cell Histiocytosis (LCH) and histiocytic neoplasms in adult patients, as well as Type 1 Neurofibromatosis (NF1) pediatric and adolescent patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas (PN). The approval of these dual indications fills the treatment gap in related rare tumor fields, offering new therapeutic options for patients.

On May 27, 2025, Junshi Biosciences' Angorici monoclonal antibody injection was approved by the NMPA for two new indications: 1) adult patients with heterozygous familial hypercholesterolemia (HeFH); 2) as monotherapy or in combination with ezetimibe for adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are intolerant or contraindicated to statins. Angorici becomes the first China-produced PCSK9-targeted drug approved for use in statin-intolerant populations.

On May 29, 2025, Fosun Pharmaceutical's innovative small-molecule CDK4/6 inhibitor "Citrate Voruciclib Capsules" was approved for marketing in China. It is indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer that has progressed after prior endocrine therapy.

May 22, 2025, Ailis/JacobiInnovative Drug Class 1, Gefapixant Citrate Tablets, Receives Conditional Marketing Approval for Adult Patients with Advanced Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation Who Have Received at Least One Systemic Therapy.

On May 20, 2025, FortuneBiotech announced that its self-developed, first-in-class (FIC) new drug 4B02-01 injection with a novel mechanism of action had received tacit approval from the Center for Drug Evaluation of the National Medical Products Administration to conduct clinical trials for the treatment of amyotrophic lateral sclerosis.

On April 25, 2025, Akeso Biopharma's Penpulimab Injection received FDA approval for marketing, indicated for two uses: first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) and treatment following disease progression after at least one platinum-based chemotherapy regimen.Penpulimab is the first self-developed innovative biologic drug by Akeso Biopharma to receive FDA approval in the United States, and also the first innovative biologic drug independently led from start to finish by a Chinese company to successfully obtain FDA approval.

On April 9, 2025, Hengrui Medicine's Class 1 innovative drug, Imecitinib Sulfate Tablets, received approval from the National Medical Products Administration (NMPA) for a new indication: for adult patients with moderate to severe atopic dermatitis (AD) who have had an inadequate response or intolerance to topical or other systemic treatments.

On April 8, 2025, Hengrui Medicine's Funaqizumab (Andajing®) was approved for an additional indication: for adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks an important breakthrough in the field of AS treatment for a recombinant anti-IL-17A humanized monoclonal antibody independently developed in China, offering new therapeutic options and hope for adult patients with AS.

On April 8, 2025, Ibrexafungerp Tablets (R&D code: HS-10366), submitted by Hansoh Pharma, were approved for marketing in China. The drug is indicated for the treatment of vulvovaginal candidiasis (VVC) in adult and postmenarcheal female patients.

As a leading integrated solution provider for clinical data and drug management in new drug research in China,Shanhu has served more than1200Clinical studies, covering the globe1000More than cities,2000Yujia Research Center, exceeding2 MillionSubject,Supports multiple international large Phase III studies.

Global Standards, Best Services: Shanhu Adheres to High-Quality, Professional Clinical Service PhilosophyTake the lead in passingFDA、EMA、PMDAPending global verification,Empower innovative pharmaceutical companies to charge ahead on the global clinical research front.