China Advances Fertility Support with Nationwide Inclusion of Assisted Reproductive Technologies in Health Insurance; Industry Updates from Yuanli Bio, BeiGene, Junshi, and More

丨Anhui and Hebei Provinces to Include Assisted Reproductive Technologies in Medical Insurance Reimbursement

On July 16, the official WeChat account of the National Healthcare Security Administration announced that starting from August 1, Anhui and Hebei provinces will include assisted reproductive technologies in medical insurance reimbursement. At that time, 14 provinces in China will have implemented medical insurance coverage for assisted reproduction. Currently, regions such as Beijing, Guangxi, Gansu, Inner Mongolia, Shanghai, Zhejiang, Jiangxi, Shandong, Qinghai, Xinjiang Uygur Autonomous Region, Xinjiang Production and Construction Corps, Jiangsu, and Jilin have introduced relevant policies. The assisted reproductive technology projects covered by medical insurance vary by region: Anhui covers 8 items, Beijing 16 items, Jiangsu 13 items, and Guangxi 9 items.

In addition, the reimbursement costs vary across regions. For instance, Hebei Province does not set a fund deductible standard, with employee reimbursement at 60% and urban and rural residents’ reimbursement at 50%, without using up the outpatient service pool of basic medical insurance. It also considers the different capacities of regional medical insurance funds to bear costs: some medical services are fully included in Category B management of medical insurance, with individuals first paying 10% out-of-pocket; Anhui Province specifies full reimbursement, 90% reimbursement, or no reimbursement for payment methods, and clearly states that the annual maximum payment limits for employees and residents are RMB 15,000 and RMB 10,000 respectively. (People's Daily Health Client, Jian Shi Ju)

丨China's National Medical Security Standardization Working Group Established

On July 18, the National Healthcare Security Administration held the inaugural meeting of the China Healthcare Security Standardization Working Group. The working group will coordinate the formulation of various healthcare security standards and promote high-quality development of healthcare security. Huang Huabo, Deputy Director of the National Healthcare Security Administration and Chairman of the China Healthcare Security Standardization Working Group, stated in a media interview that standardization is the biggest bottleneck in addressing the difficulties and pain points in current healthcare security management and services. The healthcare security standards will focus on three major areas: pharmaceuticals, medical consumables, and service items.

Currently, China's medical security standardization work has established a certain foundation, but a unified national standardization system has yet to be formed. Disparities in standards and non-recognition of data still exist in some regions, affecting policy coordination and data sharing between departments and regions. In response, the National Healthcare Security Administration has established a national medical security standardization working group.

Previously, the National Healthcare Security Administration (NHS) has successively researched, formulated, and promulgated 18 medical insurance information business coding standards for medical insurance drugs, medical consumables, medical service items, 37 technical specifications for the medical insurance information platform, as well as various standards and regulations. These efforts have fundamentally alleviated past pain points in management services such as non-unified medical insurance business standards and non-recognition of data, providing a foundation for direct settlement of medical expenses in different places, reform of payment methods, and convenient and beneficial medical insurance services for the public. (Xinhua News Agency, Economic Observer)

丨Qrigincell Therapeutics' CAR-T Therapy Granted FDA Fast Track Designation

On July 15, Qrigincell Therapeutics announced that the U.S. FDA had granted Fast Track designation to the company’s GPRC5D-targeted CAR-T cell injection (OriCAR-017) for the treatment of relapsed/refractory multiple myeloma (RRMM). The Qrigincell Therapeutics press release noted that obtaining this designation will facilitate the acceleration of clinical trials and marketing registration for OriCAR-017. Previously, the FDA had granted OriCAR-017 Orphan Drug designation and approved its Investigational New Drug (IND) application. At the 2024 ASCO Annual Meeting in early June this year, Qrigincell Therapeutics presented the 24-month long-term follow-up data of OriCAR-017 in an oral report. The data showed that OriCAR-017 demonstrated deep and durable responses in RRMM patients who had failed treatments with anti-CD38, proteasome inhibitors, immunomodulatory agents, and BCMA CAR-T therapy, with a favorable safety profile. (Qrigincell Therapeutics)

丨Betta Pharmaceuticals and EyePoint's Collaboration on New Indications for Long-Acting Ophthalmic Therapy Approved for Clinical Trials

On July 15, the official website of the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) announced that the clinical trial application for a new indication of EYP-1901 intravitreal implant, an ophthalmic treatment product co-developed by Betta Pharmaceuticals and EyePoint, has been approved. The product is intended to treat wet (neovascular) age-related macular degeneration (wAMD) patients who have previously received anti-VEGF intravitreal injections. It is reported that at the end of 2023, the Phase 2 clinical trial of EYP-1901 for wAMD conducted in the United States achieved positive topline results, demonstrating the potential for up to six months without additional treatment post-administration, showing promising development prospects. (Betta Pharmaceuticals)

丨BeiGene's Innovative Anti-Tumor ADC Approved for Clinical Trials in China

On July 15, the CDE official website announced that BeiGene's submission of the Class 1 new drug, BG-C9074 for injection, has been approved for clinical trials. The drug is intended for the treatment of advanced solid tumors. This drug is an antibody-drug conjugate (ADC) targeting the B7H4 antigen and is currently undergoing Phase 1 first-in-human clinical trials globally. According to publicly available information, in July 2023, BeiGene signed a collaboration agreement worth over $1.3 billion with DualityBio, granting it global development and commercialization rights to this ADC product. (CDE, BeiGene)

丨Bo'an Biotech's Aflibercept Biosimilar Submitted for Marketing Approval

On July 16, Boan Biotech announced that the marketing application for its self-developed aflibercept ophthalmic injection solution biosimilar (BA9101) has been accepted by the CDE. BA9101 is a biosimilar to Eylea and is intended for the treatment of adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). BA9101 is a biosimilar to aflibercept. Preclinical studies published by Boan Biotech show that BA9101 is highly similar to aflibercept in physicochemical properties and biological activity; results from the Phase 1 clinical trial (safety and tolerability comparison study) indicate that BA9101 demonstrates good safety and tolerability.

丨Eisai and Sato Pharmaceutical Reach Licensing Agreement for Antifungal Drug Flucytosine

On July 16, Eisai announced that it had entered into a licensing agreement with Sato Pharmaceutical for the development and commercialization rights of the antifungal drug fosravuconazole in Asia/Oceania regions (including ten ASEAN countries, Australia, New Zealand, South Korea, and Taiwan, China). Fosravuconazole is a novel oral antifungal drug discovered and developed by Eisai. It is a prodrug that is rapidly converted into the active ingredient ravuconazole after administration, enhancing the solubility and bioavailability of this active component. In terms of mechanism of action, ravuconazole exhibits antifungal activity by inhibiting ergosterol biosynthesis (a membrane component of fungal cells). (Eisai)

丨Qilu Pharmaceutical's AIDS Drug Approved for Marketing

On July 16, Qilu Pharmaceutical's Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets received marketing approval from the National Medical Products Administration for the treatment of HIV-1 (Human Immunodeficiency Virus Type 1) infection. This product is the first generic drug combining emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate to be approved for marketing in China. The original drug of Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets is Gilead Sciences' Odefsey. Odefsey is a triple-combination therapy (R/F/TAF), containing 200 mg of emtricitabine, 25 mg of rilpivirine, and 25 mg of tenofovir alafenamide fumarate (TAF). It was first approved for marketing in the United States in March 2016 for the treatment of HIV infection, followed by approvals in Europe and Japan. It has not yet been marketed in China. Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets are composed of emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate. Emtricitabine is a nucleoside reverse transcriptase inhibitor that blocks the synthesis of viral DNA chains. (Qilu Pharmaceutical)

丨Amgen's Innovative Therapy Submitted for Marketing Approval in China

On July 16, the CDE website announced that the marketing application for the new Class 3.1 drug Romosozumab Injection has been accepted. Public information shows that Romosozumab (trade name: Evenity), a drug with an entirely innovative mechanism for treating osteoporosis, is currently being co-developed by Amgen and UCB.

丨FusionLink Grants Global Rights for a New Radioactive Cancer Drug

On July 17, radiopharmaceuticals company Fulllink Technology announced that it had signed an out-licensing agreement with biotech company SK Biopharmaceuticals ("SK Company"). Under the agreement, Fulllink Technology grants SK Company the exclusive global rights to conduct clinical research, development, manufacturing, and commercialization of the radiopharmaceutical FL-091, targeting cancers positive for neurotensin receptor 1 (NTSR1). The total value of the deal is $571.5 million, including upfront payments, R&D and commercial milestone payments, with royalties not included. SK Company will introduce the NTSR1-targeting radiopharmaceutical conjugate (RDC) project FL-091 and its backup compounds, developing them into an innovative anti-cancer drug. SK Company also has preferential negotiation rights for other pre-selected RDC projects from Fulllink Technology. (Fulllink Technology)

丨Junshi Biosciences Anti-PD-1 Monoclonal Antibody New Indication Submitted for Marketing

On July 18, the CDE website announced that Junshi Biosciences' anti-PD-1 antibody Toripalimab injection has received approval for a new indication application. According to the official announcement by Junshi Biosciences, this indication is for use in combination with Bevacizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). Study results show that Toripalimab in combination with Bevacizumab is effective as a first-line treatment for advanced HCC patients. The safety data of Toripalimab aligns with known risks, with no new safety signals identified. Toripalimab, developed by Junshi Biosciences, is a monoclonal antibody drug targeting PD-1. Currently, this product has been approved for 10 indications in China, covering melanoma, nasopharyngeal carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, non-small cell lung cancer, renal cancer, small cell lung cancer, triple-negative breast cancer, and others. In October 2023, the drug also received FDA approval in the United States for nasopharyngeal carcinoma. This submission marks the eleventh marketing application for this drug in mainland China. (Junshi Biosciences)

丨Kinsay Biotech's Fusion Protein Product in Reproductive Field Submitted for Market Approval

On July 18, the CDE website announced that Jinsai Bio has submitted a new drug marketing application for recombinant human follicle-stimulating hormone-CTP fusion protein injection and it has been accepted. Public information shows that this product is a long-acting recombinant human follicle-stimulating hormone, mainly developed for use in the field of reproductive health. A once-weekly formulation is currently under development, which is expected to improve patient convenience and compliance. According to the registration and information disclosure of clinical trials of drugs in China, researchers have completed a Phase 3 clinical study comparing the efficacy and safety of recombinant human follicle-stimulating hormone-CTP fusion protein injection (FSH-CTP injection) with Gonal-f in Chinese female patients undergoing assisted reproductive technology. The indication is: Controlled Ovarian Stimulation (COS), used in women undergoing Assisted Reproductive Technology (ART) to promote the development of multiple follicles.(Kingseye Biotech)

「Long press」Add Xiaoda via QR code「Join the group」

Explore the forefront of market information with more industry partners