Huadong Medicine (000963.SZ) Shangke Ling Spray has been recommended by two authoritative guidelines/consensus statements, and the evidence-based value of external-use Miao medicine has once again received authoritative recognition.

On October 7, Huadong Medicine (000963.SZ) announced that Shangke Ling Spray, an exclusive product of its wholly-owned subsidiary Huadong Medicine (Guizhou) Pharmaceutical Co., Ltd., has been simultaneously included in two authoritative guidelines/consensus statements: 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)." The clinical value of external-use Miao medicine has received unanimous expert recognition, further consolidating its evidence-based medical evidence. Shangke Ling 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/consensus statements this time is both a concentrated reflection of the product's long-term evidence-based accumulation and an important footnote to Huadong Medicine's continued strengthening of its external preparation platform and improvement of its innovative product matrix. **Certification by Two Authoritative Guidelines/Consensus Statements: Evidence-Based Value of External-Use Miao Medicine Gains Authoritative Recognition** Bone and joint diseases and chronic pain are public health issues with a massive patient population and heavy disease burden in China. According to data released by the National Health Commission of China, the total prevalence rate of osteoarthritis in China is 15%, with a conservative estimate of over 100 million patients. 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 per year. Pain has become the third largest health problem after cardiovascular and cerebrovascular diseases and tumors. Shangke Ling Spray originates from a traditional Miao ethnic trauma treatment formula and is a classic ethnic traumatology medication. The formula selects native Miao medicinal materials from the Guizhou Plateau, combining ten medicinal herbs, and includes three Miao ethnic trauma-treatment medicinal materials: "Zhuadihu," "Jianxuefei," and "Tiekuazi." The finished product embodies the unique trauma treatment theory of Miao medicinebalancing blood activation and heat clearing. Its indications in the Miao medicine context are "taishe taikai, lunguan lunxi, laochong, kaidou," which correspond 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)" was led by the Joint Surgery Group of the Orthopaedic Surgery Branch of the Chinese Medical Association, and jointly developed by the Joint Group of the Orthopaedic Specialized Branch of the Shanghai Medical Association. It is an important update eight years after the first edition was published in 2018. The new edition of the consensus is based on the latest advances in the diagnosis and treatment of knee osteoarthritis in recent years, references the latest domestic and international diagnostic and treatment guidelines, follows the principles of scientific rigor, practicality, and advancement, further standardizes the clinical application of traditional Chinese medicine, incorporates specific Chinese patent medicines and clinical evidence-based data into the consensus, and promotes evidence-based clinical medication for bone and joint diseases. In the evidence overview of the recommendation that "topical external use and oral Chinese medicine can relieve knee osteoarthritis pain and improve knee joint function," Shangke Ling Spray received authoritative recommendation. The "Guidelines for Non-Surgical Treatment of Chronic Joint Pain (2026 Edition)" released in the same period was organized by the Bone and Joint Branch of the China Association of Geriatric Health Care and jointly developed by more than 90 senior experts in the field of chronic pain in China. Combining the latest evidence-based medical evidence and clinical experience, it proposes safe and reasonable non-surgical management plans for chronic pain of major limb joints including the shoulder, elbow, wrist, hip, knee, and ankle. The guidelines classify chronic joint pain under the traditional Chinese medicine categories of "bone impediment" and "impediment syndrome," dividing it into four syndrome types: wind-cold-damp impediment, wind-damp-heat impediment, blood stasis obstruction, and kidney deficiency with marrow depletion. Shangke Ling Spray is listed as the only recommended Chinese patent medicine for the wind-damp-heat impediment syndrome, and also as a recommended external-use medication for the blood stasis obstruction syndrome. The recommendation of Shangke Ling by authoritative guidelines/consensus statements means that its clinical value and evidence-based data have been recognized, providing an 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 consolidate the evidence-based medical evidence chain of Shangke Ling Spray, enhance the product's clinical value and market competitiveness, and lay a solid academic and brand foundation for accelerating the coverage of its nationwide sales network across 31 provinces and cities both inside and outside hospitals, relying on its well-established marketing network and professional pharmaceutical service team, helping the inheritance, innovation, and commercial scaling of Miao ethnic medicine. **Innovative Product Matrix Continues to Expand, Innovative Drug Commercialization Accelerates Comprehensively** The continuous consolidation of the evidence-based value of Shangke Ling Spray 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 the parent company was 1.861 billion yuan, a year-on-year increase of 2.53%; net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses was 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 operating revenue (including CSO business). The innovative business has become the core engine driving the growth of the company's pharmaceutical industry segment. At the commercialization level, Huadong Medicine has formed an integrated efficient transformation capability of "R&Dregistrationproductionsales." 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 large-scale volume growth. In the first half of 2026, the company's exclusively commercialized CAR-T product Saikaze (zevorcabtagene autoleucel injection) has covered more than 20 provinces and cities nationwide, with a cumulative 110 valid orders issued, and over 100 inclusive insurance and commercial health insurance plans have included it in their reimbursement scope. Elahere (ELAHERE), the world's first and currently only approved FR-targeting ADC for platinum-resistant ovarian cancer, has completed listing in 31 provinces, covering over 300 prescribing hospitals, and achieved sales of approximately 90.49 million yuan in the first half of the year. Multiple innovative drugs have fully benefited from the policy dividends of medical insurance access: the Class 1 new drug in the diabetes field, Huiyoujing, after inclusion in the new version of the national medical insurance catalog, has covered over 2,400 tertiary hospitals, with first-half sales revenue increasing by over 900% year-on-year; the novel PARP inhibitor Paishuning has 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 over 900 tertiary hospitals. In the autoimmune field, Sailexin/Saijiening has been prescribed at over 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 direction of innovative drug-device combinations, 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 included in relevant clinical practice guidelines. While continuously delivering commercialization results, Huadong Medicine's innovative pipeline continues to advance at high density. 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 others are accelerating clinical progress. In the oncology field, ADCs are being developed around differentiated targets such as ROR1, FGFR2b, MUC17, and CDH17, among which HDM2005 is in the global first tier in terms of progress, being the first domestically developed ROR1-targeting ADC to receive FDA Fast Track designation for mantle cell lymphoma indication. The external preparation platform to which Shangke Ling Spray belongs is precisely one of the three distinctive matrices, having laid out more than ten external preparation products with integrated full-chain capabilities in R&D, registration, production, and commercialization. From the inclusion of an exclusive Miao medicine variety in authoritative guidelines, to innovative product revenue growing 52% and multiple blockbuster varieties accelerating volume growth, Huadong Medicine is depicting a high-quality growth path driven by evidence-based medicine and innovation delivery through a "R&D + commercialization" dual-wheel drive. In the future, with the continuous consolidation of evidence-based data for Shangke Ling Spray and accelerated coverage of the nationwide sales network, 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.