According to a report from Zhitong Finance APP, on October 7, Huadong Medicine Co.,Ltd. (000963.SZ) announced that its wholly-owned subsidiary Huadong Medicine (Guizhou) Pharmaceutical Co., Ltd.'s exclusive product Shangkelin Spray has been simultaneously included in two authoritative guidelines/consensuses: the "Expert Consensus on Stepwise Treatment of Knee Osteoarthritis (2026 Revised Edition)" and the "Guidelines for Non-Surgical Treatment of Chronic Joint Pain (2026 Edition)." This marks unanimous expert recognition of the clinical value of externally applied Miao ethnic medicine, further solidifying its evidence-based medical foundation.
Shangkelin Spray is the only approved prescription drug/OTC dual-status national medical insurance Chinese patent medicine spray in China, and has been on the market for over twenty years. Its inclusion in two authoritative guidelines/consensuses this time represents both a concentrated reflection of the product's long-term evidence accumulation and an important testament to Huadong Medicine's continuous strengthening of its external preparation platform and improvement of its innovative product matrix.
Two Authoritative Guidelines Validate Evidence-Based Value of Miao Ethnic External Medicine
Bone and joint diseases and chronic pain are public health issues with a massive patient population and heavy disease burden in China. Data released by the National Health Commission of China shows that the overall prevalence of osteoarthritis in China reaches 15%, with conservative estimates putting the number of patients at over 100 million. According to the "China Pain Medicine Development Report (2020)," the number of chronic pain patients in China has exceeded 300 million and is growing at a rate of 10 million to 20 million people annually, making pain the third largest health problem after cardiovascular and cerebrovascular diseases and tumors.
Shangkelin Spray originates from a traditional Miao ethnic trauma treatment formula and belongs to classic ethnic trauma medicine. The formulation selects native Miao medicinal materials from the Guizhou plateau, combining ten medicinal herbs, and incorporates three commonly used Miao trauma treatment herbs—"Zhuadihu," "Jianxuefei," and "Tiekuaizi." The finished medicine embodies the unique Miao medical theory of trauma treatment—balancing blood activation and heat clearance. Its applicable scope in Miao medicine is "Tai She Tai Kai, Lun Guan Lun Xi, Lao Chong, Kai Dou," which corresponds in traditional Chinese medicine to clearing heat and cooling blood, activating blood circulation and removing blood stasis, and reducing swelling and relieving pain.
The "Expert Consensus on Stepwise Treatment of Knee Osteoarthritis (2026 Revised Edition)" is led by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association, jointly formulated with the Joint Group of the Orthopedics Specialized Branch of the Shanghai Medical Association. It is an important update eight years after the first edition was published in 2018. The new consensus is based on the latest advances in knee osteoarthritis diagnosis and treatment in recent years, references the latest domestic and international diagnostic and treatment guidelines, and follows the principles of scientific rigor, practicality, and advancement. It further standardizes the clinical application of traditional Chinese medicine, incorporating specific Chinese patent medicines and clinical evidence into the consensus, promoting evidence-based clinical medication for bone and joint diseases. In the evidence overview for the recommendation that "topical external application and oral Chinese medicine can relieve knee osteoarthritis pain and improve knee joint function," Shangkelin Spray received authoritative recommendation.
The "Guidelines for Non-Surgical Treatment of Chronic Joint Pain (2026 Edition)" released at the same time was organized by the Bone and Joint Branch of the China Aging Development Association, with more than 90 senior experts in the field of chronic pain jointly formulating it. Combining the latest evidence-based medical evidence and clinical experience, it proposes safe and reasonable non-surgical management plans for chronic pain of major joints of the limbs including the shoulder, elbow, wrist, hip, knee, and ankle. The guidelines classify chronic joint pain under the traditional Chinese medicine categories of "bone bi" and "bi syndrome," dividing it into four syndrome types: wind-cold-damp bi, wind-damp-heat bi, blood stasis obstruction, and kidney deficiency with marrow depletion. Shangkelin Spray is listed as the only recommended Chinese patent medicine for the wind-damp-heat bi syndrome, and also as a recommended external medication for the blood stasis obstruction syndrome.
The recommendation of Shangkelin by authoritative guidelines/consensuses means its clinical value and evidence-based proof have been recognized, providing authoritative basis for its standardized application in stepwise treatment of knee osteoarthritis and non-surgical management of chronic joint pain. For Huadong Medicine, this will powerfully solidify the evidence-based medical evidence chain of Shangkelin Spray, enhance the product's clinical value and market competitiveness, and lay a solid academic and brand foundation for accelerating the coverage of its sales network across 31 provinces and cities both inside and outside hospitals, leveraging its comprehensive marketing network and professional pharmaceutical service team, thereby facilitating the inheritance, innovation, and commercial scaling of Miao ethnic medicine.
Innovative Product Matrix Continues to Expand, Innovative Drug Commercialization Accelerates Comprehensively
The continuous solidification of Shangkelin Spray's evidence-based value is a microcosm of Huadong Medicine's innovation transformation and commercialization capabilities. According to the company's 2026 interim performance report, in the first half of 2026, Huadong Medicine achieved operating revenue of 22.067 billion yuan, a year-on-year increase of 1.81%; net profit attributable to shareholders of 1.861 billion yuan, a year-on-year increase of 2.53%; and net profit attributable to shareholders after deducting non-recurring items of 1.858 billion yuan, a year-on-year increase of 5.44%. Among this, the innovative product business achieved sales and agency service revenue of 1.684 billion yuan, a year-on-year increase of 52%, accounting for 21.14% of pharmaceutical industry revenue (including CSO business). Innovative business has become the core engine driving growth in the company's pharmaceutical industry segment.
On the commercialization front, Huadong Medicine has formed an efficient transformation capability integrating "research and development—registration—production—sales." Nearly 20 self-developed and introduced cooperative products have achieved commercial sales, among which the innovative drug R&D center has cumulatively yielded 12 marketed innovative products, with multiple blockbuster varieties entering the stage of scaled-up sales. In the first half of 2026, the company's exclusively commercialized CAR-T product Saikaize® (zevorcabtagene autoleucel injection) has covered more than 20 provinces and cities nationwide, with 110 valid orders cumulatively placed, and over 100 inclusive insurance and commercial health insurance plans have included it in their reimbursement scope. The world's first and currently only approved FRα-targeting ADC for platinum-resistant ovarian cancer, ELAHERE®, has completed listing in 31 provinces, covering more than 300 prescribing hospitals, achieving sales of approximately 90.49 million yuan in the first half of the year.
Multiple innovative drugs have fully benefited from medical insurance access policy dividends: in the diabetes field, the Class 1 new drug Huiyoujing® covered more than 2,400 tiered hospitals after inclusion in the new national medical insurance catalog, with first-half sales revenue increasing by more than 900% year-on-year. The novel PARP inhibitor Paishuning® achieved listing in all provinces of mainland China, covering nearly 1,200 medical institutions. The new-generation P-CAB Xinli'an® has covered 25 provinces and cities and more than 900 tiered hospitals. In the autoimmune field, Sailaixin®/Saijiening® has been prescribed in more than 2,000 hospitals, with domestic sales exceeding 300 million yuan in the first half of the year, a year-on-year increase of over 100%, and is expected to become a new core product in the company's autoimmune field.
In the innovative drug-device combination direction, the world's first TGFR system for real-time bedside renal function assessment has completed listing of consumables and injections in most provinces and has been incorporated into relevant clinical practice guidelines. While continuously delivering commercialization results, Huadong Medicine's innovation pipeline maintains high-density advancement. The company's innovative drug R&D center is advancing 96 innovative drug pipeline projects and has formed three distinctive product matrices: ADC, GLP-1, and external preparations, with globally first-in-class innovative drugs marketed in all three core therapeutic areas of oncology, endocrinology, and autoimmunity.
In the endocrinology field, the self-developed oral small molecule GLP-1 receptor agonist HDM1002 for weight management indication has reached the primary endpoint in China Phase III clinical trials with positive topline results and is about to submit a marketing application. The GLP-1R/GIPR dual-target agonist HDM1005 and the triple-target agonist DR10624 and other clinical programs are accelerating. In the oncology field, ADCs are being developed around differentiated targets such as ROR1, FGFR2b, MUC17, and CDH17, among which HDM2005 ranks in the global first tier and is the first domestically developed ROR1-targeting ADC to receive FDA fast track designation for mantle cell lymphoma indication.
The external preparation platform to which Shangkelin Spray belongs is precisely one of the three distinctive matrices, having laid out more than ten external preparation products and possessing integrated full-chain capabilities in research and development, registration, production, and commercialization. From the inclusion of the exclusive Miao ethnic medicine variety in authoritative guidelines, to innovative product revenue growing 52% and multiple blockbuster varieties accelerating their sales ramp-up, Huadong Medicine is outlining a high-quality growth path driven by evidence and innovation realization through a "R&D + commercialization" dual-wheel drive. In the future, as Shangkelin Spray's evidence-based proof continues to solidify and its national sales network accelerates coverage, combined with blockbuster varieties such as HDM1002, HDM1005, and DR10624 successively entering the harvest period, Huadong Medicine is expected to further release the value of its entire industry chain and build long-term competitive advantages in areas of major unmet clinical needs.
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