National Reimbursement Drug List Update and Pipeline Highlights from Yuheng Bio, Hengrui Yuanzheng, Huahao Zhongtian, Dongcheng Pharma, Fosun Henlius, Fulian Tech, Siconree, Amgen, Hope Medicine, Gan & Lee, and InnoMed

丨2024 NationalAdjustment of Medical Insurance Drug List Officially Launched

According to the official website of the National Healthcare Security Administration, the adjustment work for the 2024 National Healthcare Security Drug Catalog officially started on July 1. Based on past experience and practices, minor adjustments have been made this year. The main aspects include the following three:

First, in terms of application conditions. According to the rules, the time requirements for drug approval and modification of indications have been extended. Drugs approved for marketing or with modified indications after January 1, 2019, can be submitted for application.

Second, regarding the scope of品种 adjustment. Conventional directory drugs that have not been supplied to designated medical institutions under the medical insurance scheme in the past three years, as well as negotiated drugs that have failed to ensure market supply as per the agreement, will be considered key scenarios for strengthening supply assurance management.

Third, strengthen the supervision and management of experts. Clarify the rules for expert participation and the criteria for selection, enhance professional training and guidance for participating experts, and improve the scientific nature and standardization of review calculations. Establish and improve regulations on experts' commitment to impartial performance, confidentiality management, and external publicity.

It is reported that, in addition to removing drugs that fail to ensure market supply as per the agreement, this adjustment of the directory will include provisions on ensuring drug supply in this year's agreement text and incorporate them into performance management. This will urge pharmaceutical companies to ensure market supply after their drugs are included in the medical insurance directory through negotiation, thereby better protecting the rights of insured patients.

To stabilize corporate expectations, this year's renewal and bidding rules remain largely consistent with previous years. The payment standard validity period for the first batch of bidding varieties will expire on December 31 this year. This year’s bidding rules include an addition regarding expert review for varieties with expired payment standard validity periods to be incorporated into routine catalog management, making the rules more comprehensive. (People's Daily Online)

丨Yuheng Biotech's Introduced CXCR4 Antagonist Lands in Boao, Hainan

On July 1, Yuheng Bio announced that its core product, the innovative cell-driving factor receptor CXCR4 antagonist motixafortide, has recently been approved by the Hainan Provincial Drug Administration for an urgent clinical need import license. It has successfully landed in the Boao Lecheng Pilot Zone and will first be clinically applied at the Boao Super Hospital. Motixafortide was approved for marketing by the U.S. FDA in September 2023 as an innovative stem cell mobilizer for multiple myeloma (MM). Motixafortide is an innovative cyclic peptide CXCR4 antagonist administered via subcutaneous injection with high affinity. It binds to the CRCX4 receptor at six sites and remains effective for over 72 hours. It efficiently mobilizes stem cells from the bone marrow into the peripheral blood, ultimately allowing for the collection of the ideal number of stem cells needed for transplantation. (Yuheng Bio)

丨Hengrui Yuanzheng (Shanghai) Biotechnology Co., Ltd. Announces TCR-T Cell Product Research Results

July 1 News: Hengrui Yuanzheng announced that the company's R&D team published a research paper in the journal Nature Communications, detailing the development process, mechanism of action, and preclinical efficacy and toxicology studies of the company’s first TCR-T product, HRYZ-T101, which has entered clinical trials. Studies have confirmed that over 95% of cervical cancers are associated with human papillomavirus (HPV), with types 16 and 18 being the most common. Additionally, HPV infection can lead to various head and neck cancers as well as anogenital tumors. In tumor cells that undergo carcinogenesis following HPV infection, the E7 viral protein is persistently highly expressed, while this protein is not expressed in normal tissues, making it a potential target for targeted therapies like TCR-T. HRYZ-T101 is a TCR-T product targeting HPV18-positive solid tumors. The product is under development for the treatment of HPV18-positive solid tumors, and the first patient has been infused in the Phase 1 registrational clinical trial. (Hengrui Yuanzheng)

丨Huahao Zhongtian's Utidelone Approved for Phase 2 Clinical Trial by FDA

On July 2, Huahao Zhongtian announced that the U.S. FDA has approved its Phase 2 clinical trial (BG01-2402) for utidelone injection in treating HER2-negative breast cancer brain metastasis (BCBM). The study aims to evaluate the intracranial and systemic efficacy and safety of utidelone injection combined with capecitabine in HER2-negative BCBM patients. According to Huahao Zhongtian's press release, utidelone’s unique physicochemical properties and its insensitivity to P-glycoprotein-mediated efflux give it the ability to penetrate the blood-brain barrier. This characteristic has been fully confirmed through preclinical drug tissue distribution experiments, detection of cystic fluid in patient brain tumors, and multiple clinical studies targeting breast cancer brain metastases. (Huahao Zhongtian)

丨Lanatcheng Anti-tumor Radiopharmaceuticals Approved for Clinical Trials in the United States

July 2nd Update: Dongcheng Pharmaceutical announced that its subsidiary, Lan Nancheng Company's 177Lu-LNC1011 Injection, has received FDA approval for clinical trials in the United States and will soon commence Phase 1 clinical trials. This is a radiopharmaceutical treatment targeting Prostate-Specific Membrane Antigen (PSMA), intended for the treatment of patients with advanced prostate cancer who express PSMA positively. This marks another radiopharmaceutical treatment targeting PSMA developed by Lan Nancheng to receive FDA clinical trial approval in the U.S., following the approval of 177Lu-LNC1003 Injection. According to Lan Nancheng’s official website, the company has several other PSMA-targeted radiopharmaceutical treatments in preclinical research stages, utilizing radioactive isotopes such as 225Ac and 212Pb. (Dongcheng Pharmaceutical)

丨Henlius' Anti-PD-1 Monoclonal Antibody Approved for Phase 3 Clinical Trial in Japan

On July 2, Henlius announced that its Serplulimab Injection has been approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to conduct an international multicenter Phase 3 clinical trial. This study aims to evaluate the efficacy and safety of Serplulimab Injection in combination with Bevacizumab Injection and chemotherapy as a first-line treatment for metastatic colorectal cancer. Serplulimab, an innovative anti-PD-1 monoclonal antibody independently developed by Henlius, was approved for marketing by China’s National Medical Products Administration (NMPA) in March 2022. Currently, Serplulimab has been approved for four indications in China: 1) For the treatment of adult patients with unresectable or metastatic, highly microsatellite instability (MSI-H) advanced solid tumors who have failed standard treatments; 2) In combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC); 3) In combination with carboplatin and etoposide for the first-line treatment of extensive-stage small cell lung cancer (SCLC); 4) In combination with fluoropyrimidine- and platinum-based therapies for first-line treatment of unresectable locally advanced/recurrent or metastatic PD-L1-positive esophageal squamous cell carcinoma (ESCC). (Henlius)

丨NeuShen Pharma's Class 1 New Drug NS-136 Tablets Approved for Clinical Trials, Intended for Schizophrenia Treatment

On July 2, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced that NeuShen Pharma’s Class 1 new drug, NS-136 tablets, has been approved for clinical trials, aimed at developing a treatment for schizophrenia. According to publicly available information from NeuShen Pharma, this is a novel selective muscarinic acetylcholine M4 receptor positive allosteric modulator (M4 PAM), which has already initiated Phase 1 clinical studies in Australia. As previously introduced in NeuShen Pharma’s press releases, positively modulating the M4 receptor represents a new mechanism of action for treating schizophrenia, especially for the improvement of negative symptoms and cognitive impairments, which is considered a significant advancement in schizophrenia treatment and has garnered widespread attention. This target also shows great potential in treating psychiatric symptoms associated with Alzheimer's disease or Parkinson's disease. (NeuShen Pharma)

丨Fulink Technology's Radiopharmaceutical Conjugates Granted FDA Fast Track Designation

On July 3, Fluoropharm announced that its leading radiopharmaceutical, 225Ac-FL-020, had been granted Fast Track designation by the FDA. The drug targets prostate-specific membrane antigen (PSMA) and is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). 225Ac-FL-020 is an innovative next-generation PSMA-targeted radiopharmaceutical drug conjugate (RDC) under development by Fluoropharm. The drug is designed to treat mCRPC and is expected to enter global Phase 1 clinical trials in 2024. The product’s targeting carrier, FL-020, was developed using Fluoropharm's proprietary UniRDC™ platform, a technology that significantly enhances the drug's uptake efficiency at tumor sites while ensuring rapid systemic clearance. (Fluoropharm)

丨Sican睿奇 Innovative FGFR2 Inhibitor Granted FDA Fast Track Designation

On July 3, Siconra announced that its self-developed FGFR2 inhibitor 3HP-2827 received Fast Track designation from the U.S. FDA for the treatment of cholangiocarcinoma (CCA) patients with FGFR2 mutations. 3HP-2827 is a highly selective FGFR2 inhibitor independently developed by the company, capable of specifically inhibiting FGFR2 phosphorylation, thereby suppressing the FGFR2 signaling pathway and exerting anti-tumor effects. It offers a more effective and safer treatment option for patients with FGFR2 abnormalities, especially those with drug resistance. Previously, 3HP-2827 was approved to conduct clinical trials in both China and the U.S., intended for monotherapy or combination therapy with chemotherapy and/or immunotherapy for tumor patients with FGFR2 abnormalities. The study is currently recruiting participants. (Siconra)

丨Amgen Acquires Commercialization Rights for a Novel Autoimmune Drug in Asia and Other Regions

On July 3, Amgen announced that it had reached an agreement with CSL Vifor to obtain the commercial rights for Avacopan (brand name: Tavneos) in Asia and Latin America, including the Chinese mainland market. Avacopan is an innovative drug for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA). It has been approved for marketing in many countries around the world and has already been submitted for marketing approval in China. Avacopan is an orally administered selective complement 5a (C5a) receptor inhibitor, which can precisely block the C5a receptor located on inflammatory cells such as neutrophils, preventing these cells from being activated by C5a and reducing inflammatory damage. Currently, Avacopan has received marketing approval in eight countries: the United States, Canada, Australia, the United Kingdom, Germany, the United Arab Emirates, Japan, and South Korea. Information disclosed on the CDE’s official website shows that Avacopan hard capsules were submitted for marketing approval in China as early as December 2022. (Amgen)

丨AHB-137 Injection from Haobo Medicine Proposed for Inclusion in Breakthrough Therapy Category

On July 3, the CDE website announced that AHB-137 Injection from Haobo Medicine is proposed to be included in the breakthrough therapy designation for the indication of chronic hepatitis B. According to publicly available data from Haobo Medicine, AHB-137 is a promising antisense oligonucleotide (ASO) drug with the potential to become a cornerstone for the "functional cure" of chronic hepatitis B. According to the Chinese Clinical Trial Registry and Information Disclosure Platform, Haobo Medicine has already initiated a Phase 2 clinical study of AHB-137 Injection in patients with chronic hepatitis B in June this year. (Haobo Medicine)

丨Gan & Lee Pharmaceuticals Announces Clinical Data for GLP-1RA Biweekly Formulation

On July 4, Gan & Lee Pharmaceuticals announced the first publication of the Phase 1b/2a clinical trial results for GZR18 injection at the 84th Scientific Sessions of the American Diabetes Association (ADA) in 2024. In this study, after 35 weeks of treatment, this innovative GLP-1 receptor agonist reduced body weight by 18.6% in obese subjects. The study showed that GZR18 injection, administered once weekly or every two weeks, significantly decreased body weight in Chinese obese subjects and improved body mass index (BMI), waist circumference, and other cardiometabolic risk factors with good safety and tolerability, laying a solid foundation for its further development in overweight or obese populations. (Gan & Lee Pharmaceuticals)

丨Yinhming Biologics' Recombinant Type A Botulinum Toxin New Indication Approved for Clinical Trials

On July 5, InnoBio announced that a new clinical trial application for an innovative injectable recombinant botulinum toxin type A independently developed by its holding company, Yuyan Pharmaceutical, has been approved by the CDE. It is intended to be developed for the treatment of upper limb muscle spasticity in adults. According to InnoBio's press release, Yuyan Pharmaceutical’s recombinant botulinum toxin type A avoids the biosafety risks associated with traditional production methods without altering protein activity. Combined with its innovatively designed triple filtration technology, this botulinum toxin offers the advantages of high purity, high specific activity, and a significantly improved response rate. Previously, this recombinant botulinum toxin type A had already received CDE approval to conduct clinical trials for improving moderate to severe glabellar lines. Currently, all participants in its phase 3 clinical trial for improving moderate to severe glabellar lines have completed the study. (InnoBio) 

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