丨Medicine Hunter Club Research Team
-- On May 16, Hengrui Pharma granted Hercules, a U.S.-based company, the exclusive rights to develop, manufacture, and commercialize its proprietary GLP-1 product portfolio outside of Greater China for a fee.--On May 7, Sciwind licensed the development and commercialization rights of its GLP-1 product under research, Ecnoglutide Injection, for the Korean region to HK inno.N, a leading consumer healthcare company in Korea.--On May 7, Tonghua Dongbao Pharmaceutical Co., Ltd. acquired the exclusive commercial rights in mainland China for ZT001 (adult Type 2 diabetes), a clinical-stage product under development by Zhizhen Biologics, as well as the co-development rights for overseas markets.In May 2024, three GLP-1-related product deals were concentrated, pushing the popularity of GLP-1 to a new climax. After Eccogene licensed its small molecule GLP-1 drug to AstraZeneca for $2 billion, Hengrui Pharma set a new record with a $6 billion deal.After GLP-1 drugs obtained weight loss indications, their dual attributes in medical treatment and consumption became evident. As the most powerful target for weight loss at present, GLP-1 weight loss indications have become a hot spot for corporate transactions, such as companies with medical aesthetics business layouts. In addition, as the therapeutic effects of the GLP-1 target in the chronic disease field gradually emerge, more companies are beginning to bet on GLP-1 products for NASH indications and more metabolic chronic disease areas, strengthening their chronic disease pipelines by introducing potential products.As Semaglutide and Tirzepatide, among other significant GLP-1 products, create a "storm" worldwide, it is undeniable thatGThe number of BD deals in the LP-1 field is gradually increasing. Meanwhile, companies' strategies for product transactions are also evolving with the development of the market landscape, such as Hengrui Pharma's "packaged" overseas approach...
GLP-1 Class Drug Licensing Transactions in China (2022-2024)
"Packing" Overseas Opens New Avenues; Original Innovative Technologies Favored by MNCs
From 2022 to 2024, a total of 7 GLP-1 innovative drug BD transactions occurred.On May 16, 2024, Hengrui Pharma's GLP-1 product portfolio was licensed to U.S.-based Hercules for a minimum transaction amount of $6 billion.Chinese-produced GLP-1 small molecules have garnered favor from multinational corporations (MNCs). In November 2023, Eccogene's GLP-1 small molecule ECC5004 was licensed to AstraZeneca in a deal exceeding $2 billion. The successful overseas licensing of Chinese innovative technology has provided a confidence boost to the domestic market.1. From Domestic to InternationalTrading Company: Hengrui Pharma, HerculesProducts: HRS-7535, HRS9531, HRS-4729Transaction Amount: Over 6 Billion USDOn May 16, Hengrui Pharma granted Hercules, a U.S.-based company, the exclusive rights to develop, manufacture, and commercialize its proprietary GLP-1 product portfolio outside of Greater China for a fee.This transaction amount exceeds 6 billion US dollars, Hengrui Pharma obtained:1. The total amount of the upfront payment and recent milestone payments is US$110 million.2. Total clinical development and regulatory milestone payments not exceeding $200 million3. The cumulative sales milestone payments shall not exceed USD 5.725 billion.4. Hercules will pay Hengrui Pharma a sales royalty ranging from the low single-digit to the low double-digit percentage of actual annual net sales.5. Hengrui Pharma Acquires 19.9% Stake in U.S.-Based Hercules Company.The GLP-1 product portfolio is an innovative drug independently developed by Hengrui Pharma targeting diabetes, obesity, and other metabolic diseases, including: (1)HRS-7535, small molecule GLP-1RA; (2) HRS9531, peptide GLP-1R/GIPR dual-target agonist injection and oral product; (3) HRS-4729, next-generation incretin product.Introduction is as follows:Hercules, a U.S.-based company, was established in May 2024.The company's business scope and main business are biopharmaceutical development. Bain Capital Life Sciences, in collaboration with Atlas Ventures, RTW Capital, and Lyra Capital, jointly invested 400 million US dollars, holding 70.1% of the company's shares. The equity structure of Hercules in the United States is as follows:
Trading Companies: Sciwind, inno.NTransaction Amount: $56 Million MilestoneOn May 7, Sciwind Biosciences transferred its research and developmentGLP-1 Product Enotuglutide InjectionSciwind has granted the development and commercialization rights for the South Korean region to HK inno.N, a subsidiary of Kolmar Group, a leading consumer healthcare company in South Korea. Under the agreement, Sciwind will receive an upfront payment and is eligible to receive up to US$56 million in milestone payments related to R&D, registration, and commercialization, as well as double-digit royalties on product sales post-commercialization.Efinopegtruce is a novel long-acting GLP-1 agonist with cAMP bias., which can be used to treat type 2 diabetes, obesity, and metabolic dysfunction-associated steatohepatitis (MASLD). Preclinical in vivo studies have shown that it outperforms semaglutide in terms of blood glucose levels, insulin levels, and weight changes. Australian Phase II clinical research has shown that patients in the 26-week 2.4mg inoglycogen group experienced a weight loss reduction of -14.7% from baseline. Currently, this product is in Phase III clinical trials in China for the treatment of type 2 diabetes and obesity, and a new drug marketing application will be submitted within the year.Kolmar Group is a leader in the global cosmetics contract manufacturing industry with a century-long history. Products of cosmetic brands such as Chanel, Estée Lauder, and Lancôme are contract manufactured by Kolmar Korea, which holds one-third of South Korea's cosmetics market share. Hk Inno.N, a subsidiary of Kolmar Korea, focuses on professional biopharmaceutical development. Its CEO stated that based on the successful development and commercialization of the novel gastroesophageal reflux disease drug K-CAB, HK inno.N aims to make Enoxeglutide Injection the next blockbuster drug with sales exceeding 100 billion Korean won in the South Korean market.Trading Companies: Eccogene, AstraZenecaTransaction Amount: Over 2 Billion USDIn November 2023, AstraZeneca acquired the development and commercialization rights of ECC5004, a small molecule GLP-1 receptor agonist from Chinese company Eccogene. Eccogene received an upfront payment of $185 million, potential clinical, regulatory, and commercial milestone payments of up to $1.825 billion, as well as tiered royalties on the product’s net sales.GLP-1 receptor agonists are an important class of drugs for treating various cardiometabolic diseases. Currently, there are no orally administered small-molecule GLP-1 receptor agonist drugs approved for marketing. Compared with existing GLP-1 receptor agonist therapies on the market,ECC5004 may offer greater convenience and ease of use in terms of administration methods and dosage.。AstraZeneca's introduction of this small molecule drug further strengthens AstraZeneca's existing R&D pipeline related to incretin and non-incretin pathways.。Trading Enterprises: Hongyun Huaning (Hangzhou) Biomedical Co., Ltd., Sino BiopharmTransaction Amount: $57 Million Upfront Payment and MilestonesIn June 2023, Sino Biopharm acquired Hongyun Huaning (Hangzhou) Biomedical Co., Ltd.Dual-Target Weight Loss Innovative DrugGMA106Hongyun Huaning (Hangzhou) Biomedical Co., Ltd. will receive up to US$57 million in upfront and milestone payments from the transaction for the exclusive development and commercialization rights in Greater China.GMA106 is a GIPR antagonist/GLP-1R agonist,Using the unique M-Body technology, this product can simultaneously modulate the GIPR and GLP-1R signaling pathways.Significant therapeutic effects on obesity, non-alcoholic fatty liver disease, and diabetes.. Phase 1 clinical trial in Australia showed that GMA106 has good tolerance and safety, with no significant side effects.Moreover, the antibody has a long half-life (approximately 53 days) within its molecule.. The currently blinded efficacy data indicate that, after discontinuation of dosing (3-5 months), there is a significant prevention of weight regain following weight loss. These characteristics make GMA106 a promising candidate for a new generation of weight loss drugs that reduce weight, decrease fat, and prevent rebound after cessation. Additionally, GMA106 has substantial potential for expansion into the treatment of NASH.Transaction Enterprises: Alphamab Oncology, Amoytop BiotechTransaction Amount: RMB 490 millionIn December 2023, Alphamab Oncology and Amoytop Biotech reached an agreement to license the rights of KN056 or KN069, which were independently developed by Alphamab Oncology. Alphamab Oncology retains all rights to KN056 and KN069 outside the licensed scope, while Amoytop Biotech obtains:1. Clinical development and commercial sales of the licensed product for non-alcoholic fatty liver disease (approved indication) in mainland China;2. Aggregate maximum RMB 490 million in equity payments and a sales royalty based on a certain percentage of net sales.KN056 and KN069 are both biologic innovative drugs independently developed by Alphamab Oncology to regulate human metabolism. Among them,KN056: A New Generation of Ultra-Long-Acting GLP-1 Receptor Agonist Fusion ProteinBased on unique protein engineering technology, KN056 retains GLP-1 receptor agonist activity while demonstrating excellent in vivo stability and an ultra-long half-life. It has the potential to further reduce dosing frequency from the current weekly regimen, improving patient compliance and convenience. Currently, KN056 is undergoing Phase 1 clinical trials in healthy subjects in both China and New Zealand, with type 2 diabetes as the target indication. So far, it has shown good safety and tolerability.Transaction Enterprises: Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd., Chia-TaiTianqingTransaction Amount: RMB 342 million upfront payment and milestone paymentsIn April 2022, Chia-Tai Tianqing entered into an exclusive collaboration and licensing agreement with Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd. for the novel biologics AP025 and AP026, aimed at treating non-alcoholic steatohepatitis (NASH) and type 2 diabetes, in China and certain Asian regions. Anyuan Pharmaceutical will receive upfront and milestone payments of up to RMB 342 million, as well as tiered royalties in the single-digit percentage of net sales.AP025 is a fusion protein of human FGF21, designed to treat non-alcoholic steatohepatitis (NASH). AP025 utilizes Anyuan's proprietary linker platform technology to reduce Fc steric hindrance while preserving the biological activity of FGF21. It is the first product in China targeting the same pathway to enter clinical trials.AP026 is a FGF21/GLP-1 bifunctional protein,By utilizing Anyuan's unique linker platform technology and fusing it with the Fc region of an antibody, the stability of the molecule in the blood can be effectively enhanced. In preclinical studies, this product demonstrated advantages that make it more suitable for diabetes treatment compared to existing hypoglycemic drugs.Trading Companies: Scohia Pharma, Huadong MedicineTransaction Amount: USD 28 MillionIn February 2023, Huadong Medicine acquired the exclusive global (including Japan) development, production, and commercialization rights for SCO-094 from Japan's SCOHIA PHARMA, Inc.SCO-094 is a GIPR/GLP-1R dual-target agonist.Globally, only one GLP-1R/GIPR dual agonist, tirzepatide, has been approved for marketing. The excellent market performance of tirzepatide has also provided significant confidence in this field. The product is being developed for type 2 diabetes, obesity, and metabolic dysfunction-associated steatohepatitis (MASH), with type 2 diabetes currently in phase 1 clinical trials.One of the Strategies for Large Domestic Pharmaceutical Companies to Strengthen Their Chronic Disease PipelineLiraglutide was launched in China in 2011 for the treatment of type 2 diabetes.In July 2017, liraglutide was included in the medical insurance, after which it quickly gained momentum and captured 60.7% of China's GLP-1 receptor agonist market share.After the expiration of the liraglutide crystal patent in 2017, several companies in China have filed for biosimilars.In addition, the patent for the weight-loss star product semaglutide in China will expire in 2026, and many companies have already made advanced arrangements.
Review of Semaglutide and Liraglutide Biosimilars (Phase 3 Clinical Trials and Above) in China1. ZT001 (Semaglutide Analog)ZT001 Injection is a long-acting semaglutide analog administered once weekly, primarily used for the treatment of diabetes and obesity. In 2023, global sales of semaglutide reached $21.2 billion, ranking second on the global drug sales list. On March 5, 2024, Zhi肽 Bio initiated a Phase 3 clinical study comparing the efficacy and safety of ZT001 injection with Novo泰 in patients with type 2 diabetes.Collaboration with Aimeike on Weight Loss Indications:In March 2023, Zhipu Bio and Aimeike Technology reached a "Technology Licensing and MAH Cooperation Agreement." The two parties decided to jointly advance the clinical application and industrial production of the biosimilar Semaglutide Injection (for weight loss indication) in the Greater China region.In November 2023, Zhiping Bio completed a nearly 200 million RMB B+ round of financing, led by Aimeike.Aimeike Company was founded in 2004 and is mainly engaged in the research, development, production, and sales of biomedical materials. It has now become a leading innovative enterprise in China for soft tissue biomaterials. As a provider of innovative medical aesthetics products, Aimeike's product portfolio includes botulinum toxin for facial slimming and wrinkle reduction, as well as liraglutide injection, known as the "weight-loss needle." In November 2020, the liraglutide injection product developed by Aimeike's subsidiary, Nobot Biotech, received approval for clinical drug trials. Currently, the research on semaglutide injection for obesity is in the preclinical stage.Reach Cooperation on Type 2 Diabetes with Tonghua Dongbao Pharmaceutical Co., Ltd.:In May 2024, Tonghua Dongbao Pharmaceutical Co., Ltd. acquired the exclusive commercial rights for ZT001 (Indication: Blood glucose control in adult patients with type 2 diabetes), a clinical-stage product under development by Zhitan Biotech, for mainland China, as well as co-development rights for overseas markets.Impacted by the insulin centralized procurement, Tonghua Dongbao Pharmaceutical Co., Ltd.'s revenue in 2022 was 2.778 billion yuan, a year-on-year decrease of 14.98%. Navigating through the pressure of centralized procurement, Tonghua Dongbao has entered a new "transformation" phase. While continuing to deepen its focus on diabetes treatment, the company is continuously optimizing its R&D product portfolio. In addition to its full range of second-generation and third-generation insulin products and oral hypoglycemic drugs, it is also closely following the global mainstream R&D trends in peptide-based weight loss and hypoglycemic drugs within the GLP-1 field, actively developing multiple GLP-1 receptor agonist products. The introduction of semaglutide will create a synergistic effect with the company's existing diabetes treatment products, accelerating the establishment of a multi-layered and diversified GLP-1 product pipeline, further consolidating and strengthening the company’s core competitiveness in the fields of diabetes and endocrine metabolism.Currently, a full pipeline of GLP-1 drugs has been established, including liraglutide analogs, semaglutide analogs, GLP-1/GIP dual-target agonists THDBH 120/121, and GLP-1 small molecules THDBH 110/111.And will further explore and tap into the therapeutic potential in weight loss, NASH, and other indications.Currently, there are two liraglutide analogs available on the market in China, respectively from Huadong Medicine and Tonghua Dongbao Pharmaceutical Co., Ltd. To access a broader therapeutic market, both companies have diversified their market expansion strategies for their liraglutide analogs.Trading Enterprises: Tonghua Dongbao Pharmaceutical Co., Ltd., Kexing Biopharm Co., Ltd.In November 2023, the marketing application for Tonghua Dongbao Pharmaceutical Co., Ltd.'s liraglutide injection was approved by the NMPA for the treatment of type 2 diabetes. The approval of liraglutide marks the official entry of Tonghua Dongbao's GLP-1 class drugs into the commercialization stage, forming a strong complement to its own diabetes pipeline.As mentioned above, under the centralized procurement, companies are seeking new ways out. Tonghua Dongbao Pharmaceutical Co., Ltd. is also actively expanding its BD cooperation to accelerate the multi-market sales of Liraglutide Injection. In June 2022, Tonghua Dongbao reached a cooperation with Kexing Biopharm for Liraglutide Injection, accelerating the registration and application process of Liraglutide in 17 emerging overseas markets. To date, registration application documents for Liraglutide have been submitted in multiple countries. According to public information, Tonghua Dongbao is actively carrying out the listing and hospital entry work for Liraglutide Injection across various provinces and cities in China, hoping to achieve an initial annual sales volume of around one million units upon its market launch.Trading Enterprises: Huadong Medicine, JulpharHuadong Medicine's Liraglutide Injection has been approved for marketing in 2023 for two indications: type 2 diabetes and weight loss. In June 2022, Huadong Medicine reached a collaboration with Gulf Pharmaceutical Industries PJSC (Julphar), a leading enterprise in the Middle East, granting Julphar the rights to develop, manufacture, and commercialize the Liraglutide Injection for diabetes and weight loss in 17 countries across the Middle East and North Africa, including the UAE, Saudi Arabia, Egypt, Kuwait, Oman, and Bahrain.Julphar is one of the largest pharmaceutical manufacturers in the Middle East and Africa, as well as one of the world's leading insulin producers. It has maintained a leading position in the production and distribution of pharmaceutical products, with 12 internationally certified manufacturing plants located in the Emirate of Ras Al Khaimah, UAE.Among all the innovative layouts of Huadong Medicine, the GLP-1 field has received the most attention. Currently, the companyGLP-1 pipeline covers single-target and multi-target, injectable and oral formulations, short-acting and long-acting.Liraglutide Injection has been approved for marketing. The diabetes indication of Semaglutide Injection has completed the enrollment of all subjects in the Phase 3 clinical study. HDM1002, an orally available small molecule GLP-1 receptor agonist independently developed, has initiated Phase 2 clinical study in China.To cover more hospitals and sales channels, Huadong Medicine is actively expanding the online listing and hospital entry work for liraglutide. In addition to reaching cooperation with online sales channels such as Alibaba Health and JD Pharmacy, Huadong Medicine has completed the hospital entry of liraglutide in 1,000 hospitals and covered 20,000 terminal distribution single pharmacies.According to incomplete statistics, there are over 100 GLP-1 innovative drugs currently in clinical research in China. Hengrui Pharma's GLP-1 product portfolio, which is now expanding overseas, has not yet seen any approvals in their respective fields, making differentiated competitive advantages a crucial pivot for the international expansion of domestically produced GLP-1 products.In an era of intense competition in the GLP-1 field, with unique highlightsThe product might be the protagonist of the next deal.Featured Article Recommendations
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