Semaglutide , a long-acting GLP-1 receptor agonist, has become a core blockbuster drug in the global field of blood sugar control and metabolic weight loss due to its excellent hypoglycemic, weight loss, and cardiovascular benefits. With the expiration of Novo Nordisk's core compound patent for semaglutide in China on March 20, 2026, domestic pharmaceutical companies are accelerating their R&D, application, and patent layout efforts. Industry competition is gradually shifting from original drug monopoly to a new landscape combining domestic innovation and generic drug development. Patents serve as a core competitive barrier for pharmaceutical companies, and valid and pending patents directly reflect domestic technological reserves, R&D directions, and market competitive potential. This article, based on publicly available data from the State Intellectual Property Office, focuses on valid and pending semaglutide patents in China, systematically analyzing the technology distribution characteristics and the competitive landscape of core applicants, providing an objective reference for industry development.
I. Overview of Semaglutide Patents in China
As of September 2026, the total number of published semaglutide-related patents in China exceeded 1,000, covering various statuses including valid granted patents, those under substantive examination, those pending examination, and those rejected and invalidated. Valid and pending patents represent core technology reserves for the industry and are crucial assets for companies to compete in the market and build technological barriers, accounting for over 65% of the total. The remaining patents are mostly expired, withdrawn, or rejected.
From a time perspective, the domestic semaglutide patent landscape exhibits clear phased characteristics. Before 2018, domestic patent applications were extremely rare, with the market and technology completely monopolized by Novo Nordisk. Patent content focused solely on the original core compound, basic formulations, and delivery devices. After 2018, with the expansion of the overseas market for semaglutide and its widespread clinical application in China, domestic pharmaceutical companies began systematically deploying patents. The period from 2021 to 2024 saw a peak in applications, with an average of over 150 new patent applications per year, focusing on key technologies for domestic production, such as synthesis processes, impurity control, novel formulations, and indication expansion. From 2025 to 2026, with the expiration of original core patents, patent strategy shifts from avoiding imitation to improving and innovating, and developing differentiated technologies, with the proportion of high-quality invention patents continuing to increase.
In terms of patent type, domestic semaglutide effective and pending patents are mainly invention patents, accounting for over 92%, while utility model and design patents account for a very small percentage, consistent with the patent strategy for innovative drug development. Among invention patents, authorized effective patents are mainly related to process, crystal form, and formulation improvements, indicating high technological maturity; pending patents are mostly cutting-edge innovative technologies such as novel drug delivery systems, compound formulations, new indications, and new synthetic processes, representing the future development direction of the industry.
II. Distribution of Core Technologies in Effective and Pending Patents
Combining the efficacy and application scenarios of patent technologies, domestic semaglutide effective and pending patents can be divided into five core technology tracks. Each track shows significant differences in layout popularity, technological maturity, and competitive landscape, forming a technology distribution pattern of "process implementation as the main focus, accelerated improvement and innovation, and follow-up cutting-edge exploration."
(I) Synthetic Processes and Impurity Control Technologies (42%) This sector boasts the largest number of patents and the highest percentage of valid patents in China, forming the core foundation for the commercialization of domestically produced generic drugs. Valid patents account for 78% of the total in this sector, indicating the highest level of technological maturity. The classic synthetic process used by Novo Nordisk suffers from cumbersome steps, high levels of racemic impurities, low yields, and high production costs. Domestic pharmaceutical companies' core R&D focus is on optimizing synthetic pathways, simplifying production steps, reducing the content of key impurities, and improving the yield and purity of active pharmaceutical ingredients.
Existing valid patents largely focus on practical technologies such as solid-phase synthesis, improved liquid-phase synthesis, preparation of key intermediates, and targeted impurity removal. For example, Frontier Biotech's dipeptide feedstock preparation process patent effectively inhibits the generation of racemic impurities during synthesis, significantly improving product yield and quality stability; this patent was granted in August 2026. Many pharmaceutical companies have developed proprietary detection and control processes for the unique degradation and isomeric impurities of semaglutide, creating differentiated process barriers. Patents under review tend to focus on industrial-scale production process optimization, continuous synthesis technology, and low-cost intermediate synthesis, adapting to the needs of large-scale commercial production.
(II) Formulation Improvement and Delivery Technology (28%)
This track is the core area of differentiated competition, accounting for 45% of patents under review, demonstrating extremely high innovation activity. It primarily addresses pain points of original formulations, such as limited dosage forms, dosing frequency, storage conditions, and user experience. Original marketed dosage forms are limited to injections and oral tablets; domestic companies are intensively investing in dosage form innovation, formulation optimization, and delivery method upgrades.
Valid patents mainly focus on pre-filled syringe formulation optimization, preservative ratio adjustment, stability improvement, and room-temperature storage formulations, addressing the issues of stringent storage requirements and insufficient stability in original formulations. Patents under review offer a wider range of innovation dimensions, covering novel dosage forms such as pulmonary nebulization, long-acting sustained-release microspheres, transdermal patches, and oral instant-dissolving formulations. They also include innovative technologies such as low-dose formulations suitable for specific populations, pediatric formulations, and compound sustained-release formulations. Among them, Suzhou Yihe Pharmaceutical's patents on semaglutide mutants and fusion proteins for lung administration represent cutting-edge drug delivery technology innovation in China, breaking through the limitations of traditional injection and oral administration. In addition, some companies have optimized the formulation of pre-filled drug delivery devices, reducing the amount of phenol preservatives and improving drug safety, forming exclusive improved technology barriers.
(III) Crystal Form and API Optimization Technology (16%) Crystal form patents are one of the core barriers to drug development, directly affecting the solubility, stability, bioavailability, and formulation process compatibility of APIs. It is also a key area for companies to circumvent original patents and build independent barriers. Domestically, patents in this area are mainly valid patents, many of which are core assets of companies, with strong technological applicability.
The focus of these efforts is concentrated on new crystal form screening, crystal form preparation processes, crystal form purity control, and amorphous stability optimization. Most technologies can effectively circumvent the scope of original crystal form patent protection while improving the physicochemical properties of APIs. Some companies have developed highly stable new crystal forms, significantly improving the problems of short storage cycles and easy degradation of semaglutide APIs, providing core support for the localization of formulations. Currently, all eight semaglutide API manufacturers registered with the CDE in China have established proprietary crystal form or API purification patents, forming a closed-loop technology for API production.
(IV) New Indications and Clinical Application Technologies (9%) While the overall number of patents in this sector is relatively small, over 60% are under review, making it a core area for future innovative growth. The original semaglutide has been approved for type 2 diabetes and chronic weight management, and domestic companies are actively expanding into new clinical application scenarios to explore the long-term value of the drug.
Patents under review mainly cover emerging indications such as non-alcoholic fatty liver disease, chronic kidney disease, cardiovascular complication intervention, metabolic syndrome, and polycystic ovary syndrome, while also including medication optimization technologies for special populations (elderly patients, patients with liver and kidney dysfunction). Compared to mature process formulation technologies, the patent technology development cycle in this sector is longer, and the clinical validation threshold is higher. Currently, it is still in the technology exploration and pre-clinical layout stage, and a large number of authorized effective patents have not yet been formed. (V) Testing, Analysis, and Quality Control Technologies (5%) This track focuses on supporting technologies, with the fewest patents but extremely high practicality. Valid patents account for over 80%, essentially achieving domestic technology coverage. The scope covers the entire quality control chain for semaglutide API and formulations, including impurity detection methods, content determination, dissolution testing, stability evaluation systems, and residual solvent detection. This provides technical support for the quality compliance and consistency evaluation of domestically produced drugs, making it an essential supporting patent layout for pharmaceutical companies' commercialization.
III. Ranking and Competitive Landscape of Valid and Pending Patent Applicants
Based on a comprehensive ranking of the number of valid and pending patents, patent quality, technology applicability, and industrialization progress, domestic semaglutide patent applicants can be divided into three tiers: foreign original research companies, leading domestic pharmaceutical companies, and innovative biopharmaceutical companies. The competitive landscape exhibits the characteristics of "foreign companies holding onto high-end innovation, domestic companies seizing process formulations, and emerging companies positioning themselves in cutting-edge tracks." Tier 1: Foreign Original Research Companies (Novo Nordisk)
As the original developer of semaglutide, Novo Nordisk holds the top position in China in terms of the number of valid patents. Its core advantages lie in high-end areas such as basic innovation, core formulations, drug delivery devices, and long-acting technologies. Although its core compound patent expires in March 2026, it still holds a large number of valid derivative patents, covering formulation, drug delivery devices, indications, and long-acting modification technologies, forming a comprehensive patent barrier system and continuously locking in the high-end market.
The Supreme People's Court's final judgment on December 31, 2025, and the State Intellectual Property Office's review decision in May 2026, both upheld the validity of its core compound patent within its term, thoroughly solidifying its early-stage market monopoly. Currently, Novo Nordisk still has several next-generation combination formulations and long-acting optimization technology patents under substantive examination, continuously developing next-generation GLP-1 products to consolidate its technological leadership.
Second Tier: Leading Domestic Listed Pharmaceutical Companies (Qilu Pharmaceutical, CSPC Zhongqi Pharmaceutical, Hanyu Pharmaceutical, Huadong Medicine)
These companies boast a high total number of patents, a high proportion of valid patents, and leading industrialization progress. They are the core force driving the commercialization of domestically produced semaglutide. Their patent portfolio focuses on a three-pronged approach: process + crystal form + formulation, balancing practicality and barrier to entry.
Qilu Pharmaceutical is a benchmark company in the domestic semaglutide biosimilar development strategy, ranking first among domestic companies in terms of the number of valid and pending patents. Its focus is on optimizing synthetic processes, novel formulations, and impurity control technologies, comprehensively covering the entire industry chain from API to formulation. Its semaglutide biosimilar pipeline is leading the way, making it one of the earliest companies in China to promote commercialization. CSPC Zhongqi Pharmaceutical focuses on industrial-grade synthetic processes and large-scale production technologies. Its patents are adapted for large-scale commercial production, with outstanding advantages in impurity control and yield optimization technologies.
Qilu Pharmaceutical is a benchmark company in the domestic semaglutide biosimilar development strategy, ranking first among domestic companies in terms of the number of valid and pending patents. Its focus is on optimizing synthetic processes, novel formulations, and impurity control technologies, comprehensively covering the entire industry chain from API to formulation. Its semaglutide biosimilar pipeline is leading the way, making it one of the earliest companies in China to promote commercialization. CSPC Zhongqi Pharmaceutical focuses on industrial-grade synthetic processes and large-scale production technologies. Its patents are adapted for large-scale commercial production, with outstanding advantages in impurity control and yield optimization technologies.
Hanyu Pharmaceutical, leveraging its strengths in peptide drug R&D, focuses on raw material purification processes and crystal form technologies, having completed CDE raw material registration, with all supporting patents now valid. Huadong Medicine, deeply rooted in the GLP-1 market, while having previously launched an unsuccessful challenge to invalidate its original patents, continues to invest in dosage form improvement and formulation optimization patents, differentiating itself in niche formulation markets and avoiding homogeneous competition.
The third tier: Emerging innovative and niche pharmaceutical companies (Frontier Biotech, Suzhou Yihe Pharmaceutical, Nuotai Biotech, Paipai Biotech) Companies in this tier have fewer patents than leading pharmaceutical companies, but a very high percentage of their patents are under review. They focus on differentiated and cutting-edge technologies, avoiding homogeneous competition in traditional processes, and are an important supplement to industry innovation. Frontier Biotech's newly authorized dipeptide synthesis patent in 2026 effectively solves the industry-wide problem of racemic impurities, demonstrating significant process advantages. Suzhou Yihe Pharmaceutical focuses on novel drug delivery systems, developing lung-based drug delivery mutant technology, opening up a new drug delivery market.
Companies specializing in peptides, such as Notai Bio and Zhejiang Paitai, focus on high-end synthesis and refined purification technologies for active pharmaceutical ingredients (APIs). Their patents focus on producing high-purity, low-impurity APIs, catering to the needs of high-end formulation development, and leveraging their technological advantages to capture market share in specific segments. Furthermore, companies like CR Double-Crane Pharmaceutical, Jiuyuan Gene, and Livzon Pharmaceutical Group utilize their clinical and registration advantages to develop patents for improved formulations suitable for clinical applications, thus strengthening their product technology barriers.
IV. Core Characteristics and Industry Trends of Patent Layout
(I) Patent Layout Shifts from Imitation and Circumvention to Independent Innovation
Before 2026, domestic semaglutide patents primarily focused on process and crystal form improvements to circumvent the original drug, with the core purpose of supporting the market launch of generic drugs. As the core patents of the original drug expire, the industry's patent layout focus is gradually shifting to original improvements and innovations such as dosage form innovation, new indication expansion, compound formulations, and novel drug delivery technologies. The innovation dimensions of patents under review are continuously upgrading, and the industry is transforming from "imitation and following" to "differentiated innovation." (II) Significant Differentiation in Technological Tracks and Gradual Formation of Sub-Segment Barriers
Leading pharmaceutical companies are deeply cultivating technologies across the entire industry chain, building a complete patent matrix encompassing process, crystal form, formulation, and quality control; emerging companies are focusing on single cutting-edge tracks, forming segment barriers through differentiated technologies; foreign companies are adhering to high-end innovation and next-generation product development. Technological barriers in each track are gradually solidifying, alleviating the pressure of homogeneous competition, and technological advantages in sub-segments are becoming the core competitiveness of enterprises.
(III) Deep Integration of Patents and Industrialization
Almost all valid domestic patents correspond to technologies for industrialization, with no large amount of invalid or redundant patents. The 8 CDE (Center for Drug Evaluation) API registration companies, 12 companies that have submitted formulation marketing applications, and 26 companies that have received clinical trial approvals all have well-developed core patent systems. Patent layouts precisely serve drug registration, commercial production, and market competition, demonstrating strong industrial applicability.
V. Conclusion
The current Chinese semaglutide patent market presents a pattern of "solid original research barriers, rapid domestic follow-up, and continuous innovation iteration." Valid patents focus on mature and commercialized technologies such as synthesis processes, crystal forms, and traditional formulations, supporting the commercialization of domestically produced generic drugs. Patents under review focus on novel dosage forms, new indications, and cutting-edge drug delivery technologies, defining the future direction of innovation in the industry. The applicant landscape is clearly stratified: leading pharmaceutical companies drive industrialization, emerging companies empower niche innovations, and foreign companies continue to lead high-end technology R&D.
As domestic generic semaglutide drugs are successively approved for market launch, industry patent competition will further shift from process improvement to a battle of innovation barriers. Companies possessing core patents in differentiated formulations, new indications, and high-end APIs will dominate subsequent market competition, propelling the domestic GLP-1 drug industry from a generic era to a high-quality, innovative development era.
Shaanxi Lv Ke Chun Yuan Biotechnology Co., Ltd
Our address
Huaxia Yue World, Weibin District, Baoji City, Shaanxi Province
Phone Number
+86-13571783771
