Aankondiging • Jun 27
Sihuan Pharmaceutical Holdings Group Ltd. Approves Final Cash Dividend for the Financial Year Ended December 31, 2025, Payable on July 16, 2026 Sihuan Pharmaceutical Holdings Group Ltd. at its annual general meeting held on June 26, 2026, approved the payment of a final cash dividend of 0.96 RMB cents per share for the financial year ended December 31, 2025. The final cash dividend payable to Shareholders shall be converted to and paid in HKD. The exchange rate adopted for conversion was based on the exchange rate of RMB 1 to HKD 1.133 as of 31 March 2026 (being the medium exchange rate of RMB to HKD as announced by the Peoples Bank of China on the date of the Board meeting). Accordingly, the amount of the final cash dividend payable in HKD will be 1.09 Hong Kong cents per share. The final cash dividend will be payable on 16 July 2026 to Shareholders whose names appear on the register of members of the Company on 6 July 2026. Aankondiging • Jun 24
Sihuan Pharmaceutical Holdings Group Ltd. Announces First Patient Has Been Successfully Enrolled Recently in the Phase Iii Clinical Study of Anaprazole Sodium Enteric-Coated Tablets The board of directors of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that the first patient has been successfully enrolled recently in the Phase III clinical study of Anaprazole Sodium Enteric-coated Tablets (trade name: An Jiu Wei), an innovative drug independently developed by Xuanzhu Biopharmaceutical Co. Ltd. ("Xuanzhu Biopharm", stock code: 02575.HK), a non wholly-owned subsidiary of the Group, as part of a bismuth-containing quadruple therapy for the eradication of Helicobacter pylori ("Hp"), marking that this key registration clinical study has officially entered the substantive execution stage. This Phase III clinical trial is a multi-centre, randomized, double-blind, double-dummy, active-drug parallel-controlled trial, which plans to enroll 556 adult subjects who are Hp positive. Using bismuth-containing quadruple therapy containing esomeprazole magnesium as the active control, the trial aims to evaluate the efficacy, safety and population
pharmacokinetic characteristics of bismuth-containing quadruple therapy containing anaprazole sodium administered continuously for 14 days for Hp eradication. The primary endpoint is Hp eradication rate confirmed by 13C-urea breath test ("13C-UBT") on day 28 after the completion of treatment. Hp is a Gram-negative microaerophilic pathogenic bacterium closely associated with a variety of gastric diseases, including gastric ulcer, chronic progressive gastritis and gastric cancer. According to Frost & Sullivan, the infection rate of Hp in China is approximately 44%, and the market size of drugs for the treatment of Hp infection continues to expand. The market size in China reached RMB5.5 billion in 2024, and is projected to increase to RMB 6.8 billion in 2029 and reach RMB 12.6 billion in 2035. Following the approval to initiate the Phase III clinical trial for Hp eradication indication by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration
("NMPA") of the People's Republic of China ("China") in April 2026, the first patient was enrolled rapidly, which fully demonstrates the efficient execution capability of Xuanzhu Biopharm's clinical development team and marks that the project has officially entered the key stage of clinical implementation. If this indication is successfully approved for marketing in the future, it is expected to further expand the target patient population of anaprazole sodium, accelerate the product's market penetration, and create a new performance growth driver for the Company and Xuanzhu Biopharm in the digestive field. Anaprazole Sodium Enteric-coated Tablets (trade name: An Jiu Wei) was approved for marketing by NMPA in June 2023 for the treatment of patients with duodenal ulcer. Anaprazole Sodium features an innovative structural design with characteristics including non-enzymatic plus multi-enzymatic metabolism and balanced intestinal-renal dual-channel excretion, with only 3.5% metabolized through CYP2C19, making it unaffected by CYP2C19 gene polymorphism. Compared with previous generations of proton pump inhibitors, Anaprazole Sodium has lower risk of drug-drug interactions, making it a safer choice for
patients on multiple medications and those with renal impairment, and is a proton pump inhibitor more suitable for the Chinese population. As a Class 1 innovative drug in China, Anaprazole Sodium fills the gap in domestically developed proton pump inhibitors, bringing treatment options with both superior efficacy and safety to Chinese patients. Aankondiging • Apr 21
Sihuan Pharmaceutical Holdings Group Ltd. Announces Preliminary Results of Ng-350A Phase 1B Fortress Clinical Study Sihuan Pharmaceutical Holdings Group Ltd. announced that preliminary results from the Phase 1b FORTRESS study of NG-350A were presented at the 2026 Annual Meeting of the American Association for Cancer Research on 20 April 2026. NG-350A, an oncolytic immunotherapy being developed for the treatment of mismatch repair-proficient locally advanced rectal cancer, was in-licensed by Xuanzhu Biopharmaceutical Co. Ltd., a non wholly-owned subsidiary of the Group, from Akamis Bio Inc., a clinical-stage oncology company working to advance the standard of care in colorectal cancer. The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy in adult patients with mismatch repair-proficient locally advanced rectal cancer and at least one risk factor for local or distant recurrence or with oligometastatic disease. The ongoing study is assessing the anti-tumor effects of NG-350A combined with chemoradiotherapy following a 12-week active treatment period to establish whether NG-350A can improve composite response rates-defined as the proportion of patients achieving a clinical complete response or a near clinical complete response in mismatch repair-proficient locally advanced rectal cancer patients relative to expected outcomes from chemoradiotherapy alone. The benchmark composite response rate (clinical complete response + near clinical complete response) with chemoradiotherapy alone at 12 weeks is approximately 25%. The study results demonstrate a 50% composite response rate in the first 10 patients who completed the 12-week active treatment period, with no serious adverse events or new safety signals identified related to NG-350A. NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn®) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells resident in solid tumors and their draining lymph nodes. Once activated, antigen-presenting cells recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression. Xuanzhu Biopharm holds exclusive rights to the development, manufacturing and commercialization of NG-350A in Greater China. Xuanzhu Biopharm is actively advancing the application for clinical trials of NG-350A in the People’s Republic of China. Aankondiging • Apr 03
Sihuan Pharmaceutical Holdings Group Ltd. Proposes Final Cash Dividend for the Year Ended 31 December 2025, Payable on 16 July 2026 Sihuan Pharmaceutical Holdings Group Ltd. recommended the declaration and payment of a final cash dividend of RMB 0.96 cents per share (equivalent to 1.09 Hong Kong cents per share) for the year ended 31 December 2025 (2024: Nil) in thanking Shareholders' support, subject to the approval by the Shareholders at the Annual General Meeting. The final cash dividend payable to Shareholders shall be converted to and paid in HKD. The exchange rate adopted for conversion was based on the exchange rate of RMB 1 to HKD 1.133 as of 31 March 2026 (being the medium exchange rate of RMB to HKD as announced by the People's Bank of China on the date of the Board meeting). The register of members of the Company will be closed from Friday, 3 July 2026 to Monday, 6 July 2026 (both dates inclusive). In order to qualify for the final cash dividend, all transfers accompanied by the relevant share certificates must be lodged with the Company's Hong Kong branch share registrar, Tricor Investor Services Limited, at 17/F, Far East Finance Centre, 16 Harcourt Road, Hong Kong on 2 July 2026. The final cash dividend, subject to the approval by the Shareholders at the Annual General Meeting, will be payable on Thursday, 16 July 2026 to the Shareholders whose names appear on the register of members of the Company on 6 July 2026. Aankondiging • Mar 31
Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 26, 2026 Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 26, 2026. Aankondiging • Mar 19
Sihuan Pharmaceutical Holdings Group Ltd. to Report Fiscal Year 2025 Results on Mar 31, 2026 Sihuan Pharmaceutical Holdings Group Ltd. announced that they will report fiscal year 2025 results on Mar 31, 2026 Aankondiging • Jan 16
Sihuan Pharmaceutical Holdings Group Ltd. Announces Approval Of Six New Specifications Of PLLA Filler By NMPA Sihuan Pharmaceutical Holdings Group Ltd. announced that six new specifications of the polylactic acid facial filler (market abbreviation "PLLA filler") independently developed by Meiyan Space Biotechnology (Jilin) Co. Ltd., a subsidiary of the Group, have been approved by the National Medical Products Administration of China (NMPA). This is another important development after the product was first approved, further improving the Company's market layout in the field of regenerative medical aesthetic products. Sihuan Pharmaceutical's PLLA filler achieves the dual effect of "instant filling + long-term regeneration" with the core ingredient of Poly L-lactic acid (PLLA) microspheres. Its unique patented technology ensures that the microsphere morphology is regular, the particle size is uniform, and the safety and clinical efficacy are excellent. Most patients can maintain effective effects for one year after injection. Prior to this specification expansion, the product has already been approved in three specifications, including 45 mg/bottle, 75 mg/bottle and 150 mg/bottle, which are suitable for different needs such as preventive management, combination therapy, and comprehensive rejuvenation; The six newly approved specifications, including 60 mg/bottle, 80 mg/bottle, 100 mg/bottle, 110 mg/bottle, 120 mg/bottle, 130 mg/bottle, will further enrich the product selection spectrum. The value and significance of this specification expansion are as follows: Precise matching of diverse anti-aging needs: The new specifications fill the dosage gap between existing specifications, achieving full scene coverage from mild early aging to moderate to severe aging. Whether it is slight dullness improvement in delicate areas or moderate fullness demand in facial contours, personalized treatment can be achieved through precise dosage selection, meeting the specific needs of different age groups. Optimizing clinical operation flexibility: Based on the product's ability to quickly dissolve within 1 minute, multiple specifications are available for doctors to flexibly adjust dilution concentration and injection dose according to the injection site and treatment depths, reducing the complexity of combination therapy and improving treatment efficiency and safety. Strengthening market competition barriers: Against the backdrop of PLLA filler's market sustained growth in the global and intense domestic competition, the multi specification layout further consolidates the differentiated advantages of Sihuan Pharmaceutical in the field of regenerative medical aesthetic, forming a synergistic effect with its products such as "PCL filler" and "Double Wave RF", and improving the product matrix of the medical aesthetic category. Promoting the refined development of the industry: This specification expansion responds to the trend of the medical aesthetic industry from "standardized treatment" to "personalized solutions". Through dose segmentation, it guides the industry to focus on individual differences of patients and provides industry reference for the specification design of regenerative medical aesthetic products, helping the industry upgrade towards high-quality and refined direction. Sihuan Pharmaceutical will rely on a strong sales channel network covering over 7,000 medical institutions to quickly promote the market landing of new specifications, continue to empower medical aesthetic product innovation with pharmaceutical companies' research and development genes, provide consumers with safer, more accurate, and diversified anti-aging solutions, and promote the medical aesthetic sector of the Group to enter a new stage of large-scale growth. Aankondiging • Aug 22
Sihuan Pharmaceutical Holdings Group Ltd. Announces Innovative Drug Dirozalkib Tablets Independently Developed by Xuanzhu Biopharm Obtained Drug Registration Approval from Nmpa The board of directors of Sihuan Pharmaceutical Holdings Group Co. Ltd. announced that the Class 1 innovative drug anaplastic lymphoma kinase (ALK) inhibitor Dirozalkib Tablets (formerly known as "D exitinib", XZP-3621, brand name: Xuan Fei Ning) independently developed by the Group's non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co. Ltd. ("Xuanzhu Biopharm"), has obtained a drug registration approval from the National Medical Products Administration (the " NMPA") for the treatment of ALK-positive advanced non-small cell lung cancer ("NSCLC"). This product is the third Class 1 innovative drug approved for launch by Xuanzhu Biopharm, and also the second Class 1 innovative anti-tumor drug approved for launch by XuanZhu Biopharm, this marks the continuous leap from breast cancer to lung cancer targeted treatment in the oncology research and development ("R&D"). Dirozalkib has four core advantages, including (1) Rapid onset of action: Dirozalkib significantly improves the bioavailability through its unique molecular structure design, which can quickly inhibit tumor progression and secure a critical treatment window for patients. With excellent anti-tumor performance: In pivotal Phase III clinical trials, Dirozalkib demonstrated significantly superior efficacy compared to the marketed first- and second-generation ALK inhibitors in the treatment of ALK- positive advanced NSCLC patients, and showed strong inhibitory activity against drug-resistant mutations including G1202R and I1171N. Persistent relief: The patient's benefit time was significantly prolonged, laying a foundation for long-term disease stability. Significant survival benefits: Dirozalkib can truly achieve the goal of "chronic disease management". In addition, Dirozalkib has successfully solved clinical problems and achieved a dual breakthrough in brain metastasis control and safety. It can penetrate the blood-brain barrier efficiently, effectively compensating for the shortcomings of existing therapies in central nervous system protection. In terms of safety, Dirozalkib have shown significant advantages, the main adverse reactions are diarrhea and vomiting, mostly of grade 1-2, which can be relieved or cured through symptomatic treatment and/or dosage adjustment. In addition, the risks of pleural effusion and liver toxicity were significantly reduced, which significantly improved the long-term medication adherence of patients. According to data from China Insights Consultancy (CIC), there was about 91,200 ALK-positive NSCLC patients in China in 2024, and it is expected to reach 121,700 by 2032, with a compound annual growth rate of 3.7%; In 2024, the market size of ALK inhibitors in China was approximately RMB 4.7 billion, and it is predicted to increase to RMB 8.9 billion by 2032, with a compounds annual growth rate of 8.3%. Dirozalkib approved for launch this time, it is not only an important milestone in R&D of Xuanzhu Biopharm's innovative drug pipeline, but also provides a breakthrough treatment option for ALK-positive NSCL C patients in China. With its significant clinical advantages, it will effectively improve the quality of life of patients, accelerating the achievement of the cancer prevention and control goal of "Healthy China 2030". Aankondiging • Aug 19
Sihuan Pharmaceutical Holdings Group Ltd. to Report First Half, 2025 Results on Aug 29, 2025 Sihuan Pharmaceutical Holdings Group Ltd. announced that they will report first half, 2025 results on Aug 29, 2025 Aankondiging • Mar 28
Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 06, 2025 Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 06, 2025. Aankondiging • Mar 18
Sihuan Pharmaceutical Holdings Group Ltd. to Report Fiscal Year 2024 Results on Mar 28, 2025 Sihuan Pharmaceutical Holdings Group Ltd. announced that they will report fiscal year 2024 results on Mar 28, 2025 Aankondiging • Aug 30
Sihuan Pharmaceutical Holdings Group Ltd. Announces Interim Ordinary Cash Dividend for the Six Months Ended June 30, 2024, Payable on 10 October 2024 Sihuan Pharmaceutical Holdings Group Ltd. announced interim ordinary cash dividend of HKD 0.019 per share for the six months ended June 30, 2024. The Dividend will be payable October 10, 2024 of record date as of October 3, 2024 with ex-dividend date September 27, 2024. Aankondiging • Aug 20
Sihuan Pharmaceutical Holdings Group Ltd. to Report First Half, 2024 Results on Aug 30, 2024 Sihuan Pharmaceutical Holdings Group Ltd. announced that they will report first half, 2024 results on Aug 30, 2024 Aankondiging • Jun 26
Sihuan Pharmaceutical Holdings Group Ltd.'s Honghe Pharmaceutical Co., Ltd. Obtains Drug Registration Approval from National Medical Products Administration The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that Ticagrelor Orodispersible Tablet (Strength: 90 mg)(the ‘Product’), developed by the Group's subsidiary Honghe Pharmaceutical Co. Ltd. has obtained drug registration approval from the National Medical Products Administration of the People's Republic of China. It is deemed as passing the consistency evaluation on quality and efficacy of generic drugs. The Product developed by Honghe Pharmaceutical is the first domestic product to be approved for launch. Ticagrelor is a novel antithrombotic drug with strong antiplatelet aggregation to prevent thrombosis. It has been recommended by Chinese and international guidelines as an antiplatelet agent for thrombosis prevention in patients with cardiovascular disease. Ticagrelor Orodispersible Tablet is classified as Class B drug under the National Reimbursement Drug List (NRDL). According to public data, the Farber Core Hospital Market Data shows that the market size of oral anticoagulant drugs in core hospitals in China exceeded RMB 10 billion in 2023. The cardiovascular and cerebrovascular field is a key deployment field of Group. The approval of Ticagrelor Orodispersible Tablet will further benefit patients and add another significant variety to the Group's cardiovascular and cerebrovascular drug pipeline, and will have a positive impact on the operating performance of the Group. Aankondiging • Jun 13
Sihuan Pharmaceutical Holdings Group Ltd. Announces Rivaroxaban Tablets (Strength: 2.5Mg) Obtained Drug Registration Approval from NMPA Sihuan Pharmaceutical Holdings Group Ltd. announced that the supplementary application for the new strength (2.5mg) of Rivaroxaban Tablets developed by the Group's subsidiary Jilin Sihuan Pharmaceutical Co. Ltd. (the "Jilin Sihuan") has been approved by the National Medical Products Administration (the " NMPA") of the People's Republic of China (the "China"). The combination of Rivaroxaban TableTS (strength:2.5mg) and Aspirin can be seen as a new product, with different indications to the already marketed Rivaroxaban Tablets (strength:10mg and 15mg) (used for adult venous thromboembolism (VTE), deep venous thrombosis (DVT), pulmonary embolism (PE), and non-valvular atrial fibrillation). The indication of Rivaroxaban Tablet (strength:2.5 mg) is that Rivaroxaban Tablets combined with Aspirin (ASA) is used in adult patients with coronary artery disease (CAD) or peripheral arterial disease (PAD) at high risk of ischemic events, to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke). It is deemed to have passed the consistency evaluation on quality and efficacy of generic drugs. For Rivaroxaban Tablets (" strength:2.5mg), Sihuan Pharmaceutical is the third domestic company approved for marketing. Rivaroxaban is a Class B drug under the National Reimbursement Drug List (NRDL), and it's a new type of oral anticoagulant drug widely used clinically. It has the advantages of rapid onset, low incidence of intracranial hemorrhage, and no need for routine coagulation monitoring and dose adjustment. The combination of Rivaroxab and Aspirin can significantly improve the prognosis of CAD/PAD patients, and it is recommended by authoritative guidelines in Europe, United States, and China. In the first half of 2023, among the top 10 sales of antithrombotic drugs in China, Rivaroxaban is the only oral anticoagulant Drug. According to public data, there are approximately 11 million CAD patients and 45.3 million PAD patients in China currently. The cardiovascular and cerebrovascular field is one of the key focus area of the Group. Sihuan Pharmaceutical's Rivaroxaban Tablets(strength: 10mg, 15mg) were approved in China in March 2021 and were included in the national volume-based procurement in June 2021. The approval of Rivaroxaban Tableting (strength: 2.5mg) will further benefit patients and add another significant variety to the Group's pipeline in cardiovascular and cerebrovascular fields, which will benefit the future market sales and competition of this product, and will have a positive impact on the operating results of the Group. Aankondiging • Mar 29
Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 07, 2024 Sihuan Pharmaceutical Holdings Group Ltd., Annual General Meeting, Jun 07, 2024. Aankondiging • Jan 23
Sihuan Pharmaceutical Holdings Group Ltd. Receives Registration Approval from National Medical Products Administration for Proline Janagliflozin Tablets The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that, Proline Janagliflozin tablets (Trade Name: Huiyoujing, a sodium glucose transporter 2 inhibitor ("SGLT-2 inhibitor") and national Class 1 innovative drug, developed by Huisheng Biopharmaceutical Co. Ltd. (Huisheng Biopharmaceutical), a non-wholly owned subsidiary of the Group, has obtained drug registration approval from the National Medical Products Administration (the "NMPA") of the People's Republic of China (China) for the treatment of type 2 diabetes. This will be the second self-developed SGLT-2 inhibitor innovative drug approved and marketed in China, which marks the breakthrough progress of Huisheng Biopharmaceutical in the research and development of innovative drugs in the field of diabetes treatment. The SGLT-2 inhibitor is a new type of oral hypoglycemic drug highly recommended internationally for the treatment of patients with type 2 diabetes mellitus. It selectively inhibits the SGLT-2 receptor in renal proximal tubules, to reduce glucose re-absorption and promote urinary glucose excretion, thus lowering blood glucose concentration. SGLT-2 inhibitors not only have good hypoglycemic effect, but also have multiple benefits such as cardiovascular and renal protection, which is recommended by domestic and foreign guidelines in multiple fields, and also have the potential to expand to cardiovascular disease, chronic kidney disease and other indications. Janagliflozin, as a SGLT-2 inhibitor, is a national Class 1 innovative drug, and its phase III clinical data showed that it not only has significant hypoglycemic efficacy (the decrease of HbA1c is up to 1.4% compared to baseline), but also has multiple benefits such as lowering blood pressure, reducing weight and improving blood lipids, etc., with low risk of hypoglycemia, and good overall safety. When compared side-by-side with phase III clinical data of similar SGLT-2 inhibitor products already on the market, Janagliflozin showed similar or even better results. Huisheng Biopharmaceutical owns the patent rights of Janagliflozin in multiple countries and regions including China, the United States, Europe, Japan, South Korea and Hong Kong, etc. Aankondiging • Jan 08
Sihuan Pharmaceutical Holdings Group Ltd. Obtains Drug Registration Approval from the National Medical Products Administration of the People's Republic of China for the Treatment of Diabetes Sihuan Pharmaceutical Holdings Group Ltd. announced that Insulin Aspart Injection, Insulin Aspart 30 Injection and Insulin Aspart 50 Injection developed by Huisheng Biopharmaceutical Co. Ltd. ("Huisheng Biopharmaceutical"), a non-wholly owned subsidiary of the Group, have obtained drug registration approval from the National Medical Products Administration (the " NMPA") of the People's Republic of China ("China") for the treatment of diabetes. As the first insulin product approved for marketing of Huisheng Biopharm pharmaceutical, it is a new milestone for Huisheng Biopharm Pharmaceutical to officially move from the research and development stage to the commercialization stage of its full range of products in the field of diabetes and complications. Insulin Aspart Injection is the third-generation fast acting insulin analogue. It takes effect within 10-20 minutes after subcutaneous injection, which can better control postprandial blood glucose and reduce the risk of hypoglycemia. The injection time is more flexible and can be administered near mealtime, it can also be used for insulin pump and intravenous injection. Insulin Aspart 30/50 Injections are biphasic insulins containing 30%/50% soluble insulin aspart and 70%/50% protamine insulin aspart. They can better control fasting and post-prandial blood glucose, reduce the number of injections, and has obvious advantages in improving patients' compliance and saving medical costs. The availability of two different dosages allows clinical physicians to provide patients with more flexible and personalized treatment options based on their postprandial blood glucose levels. Insulin Aspart In injection, Insulin Aspart 30 in the National Reimbursement Drug List (2023 version) and classified in Category B. Diabetes is prevalent in China, where the number of diabetes patients ranks first in the world. According to the latest report of IDF, there was 140 million diabetes patients in China in 2021. As a chronic disease, diabetes patients require lifelong use of hypoglycemic drugs. Insulin and its analogues play an important role in the treatment of diabetes, accounting for more than 50% of the market share in diabetes drugs, with huge demand. According to the annual report of Novo Nordisk, revenue of the three Insulin Aspart products in the Greater China reached RMB 5.9 billion in 2022. Aankondiging • Oct 26
National Medical Products Administration Approves IND Application of Insulin Degludec and Liraglutide Injection, Developed by Huisheng Biopharmaceutical The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that, the investigational new drug (IND) application of insulin degludec and liraglutide injection, developed by Huisheng Biopharmaceutical Co. Ltd. ("Huisheng Biopharmaceutical"), a non-wholly owned subsidiary of the Group, for the treatment of type 2 diabetes has been approved by the National Medical Products Administration (the " NMPA") of the People's Republic of China ("China"). Insulin degludec and lIRaglutide injection is the first marketed compound in the world composed of basic insulin analog and GLP-1 analog. It combines the two-component advantages of insulin degludec & liraglutide, has a significant effect on blood glucose lowering and shows weight loss efficacy at the same time. It is used to treat type 2 diabetes. Insulin degludec & lIRaglutide injections is injected once a day, reducing the frequency of injections and improving medical adherence in patients. When the dosage of insulin is same or lower, its blood glucose lowering effect is superior to basic insulin treatment alone, meanwhile reducing the risk of hypoglycemia and eliminating the side effects of insulin treatment on weight gain. Insulin degludEC and liraglutides injection is recommended in the China Guideline for Type 2 Diabetes (2020 Edition). It belongs to Category B drug under the National Reimbursement Drug List ("NRDL"). China has the largest number of diabetes patients in the world. The number of diabetes patients was about 140 million in 2021, and it is predicted that it will increase to 174.4 million in 2045. As a chronic disease, diabetes needs lifelong medication, so the diabetes market has a huge demand. Insulin degludeca and liraglutIDE injection, currently only marketed by its developer Novo Nordisk in China, was approved for marketing in China in October 2021 and was included in the NRDL in 2022. It is currently in a rapid expansion period in China. Aankondiging • Aug 18
Sihuan Pharmaceutical Holdings Group Ltd. to Report First Half, 2023 Results on Aug 29, 2023 Sihuan Pharmaceutical Holdings Group Ltd. announced that they will report first half, 2023 results on Aug 29, 2023 Aankondiging • Jul 06
Sihuan Pharmaceutical Holdings Group Ltd. Announces Huisheng Biopharmaceutical's Drug Semaglutide Injection Obtained Approval for Clinical Trial The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that, Huisheng a peripheral neuropathy drug developed by Huisheng Biologicals Co. Ltd., a non-wholly owned subsidiary of the Group, has been approved for clinical trials from the National Medical Products Administration (the "NMPA") of the People's Republic of China ("China") of Semaglutide Injection for the treatment of type 2 diabetes. In addition, Thioctic Acid Injection, a peripheral neuropathy (PN) drug developed by Huisheng Biopharmaceutical, has recently obtained the drug registration approval from NMPA, which is deemed to have passed the consistency evaluation on quality and efficacy of generic drugs. Semaglutide is a long-acting GLP-1 receptor agonist (GLP-1RA) injected once a week, which not only has the potential to potently lower glucose, but also to significantly reduce weight, lower blood pressure, improve lipid profiles and reduce the risk of major cardiovascular adverse events, thereby increasing patient compliance and improving quality of life over the classic GLP-1 receptor agonist drug liraglutide. It is recommended for use in patients with type 2 diabetes mellitus (T2DM), cardiovascular disease or patients at very high cardiovascular risk. Aankondiging • Jul 04
Sihuan Pharmaceutical Holdings Group Ltd. Announces Approval of Phase II Clinical Trial Application of Birociclib by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that the Phase II clinical trial application of Birociclib (XZP-3287, CDK4/6 inhibitor), a class 1 innovative drug under development by the Group's non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co. Ltd. ("Xuanzhu Biopharmaceutical"), used as monotherapy or in combination with Abitherone acetate and prednisone in the treatment of metastatic prostate cancer has been approved by the Center for Drug Evaluation of the National Medical Products Administration (the " NMPA") of the People's Republic of China. Prostate cancer is one of the common malignant tumors in the genitourinary system of elderly men. Its incidence rate and mortality rate rank second and fifth in the global spectrum of male malignant tumors, and sixth and seventh in Chinese men respectively. According to global market research and consulting firm Nova One Advisor, the global prostate cancer treatment market size is estimated to be $15.2 billion in 2021 and is expected to increase to $24.9 billion by 2030. Aankondiging • Jun 02
Sihuan Pharmaceutical Holdings Group Ltd. Obtains Drug Registration Approval from the National Medical Products Administration The board of directors of Sihuan Pharmaceutical Holdings Group Ltd. announced that the mecobalamin tablets (specification: 0.5mg), a peripheral neuropathy drug developed by the Group's non-wholly owned subsidiary, Huisheng Biopharmaceutical Co. Ltd. ("Huisheng Biopharmaceutical"), has obtained drug registration approval from the National Medical Products Administration (the "NMPA") of the People's Republic of China ("China"), and is deemed to have passed the consistency evaluation on quality and efficacy of generic drugs. Mecobalamin tablet is Huisheng Biopharm Pharmaceutical's first drug approved for marketing, and also the first anti diabetes complication drug approved for marketing. which remarks the new milestone of Huisheng Biopharm pharmaceutical's anti diabetes complication drugs from research and development to commercialization. Mecobalamin is an endogenous coenzyme B12 that is not metabolised by the liver and does not require biotransformation and can directly play an active role. It is used clinically in the treatment of various peripheral neurological conditions such as neuralgia, facial paralysis, neuritis and neurological disorders. It is also used in the treatment of diabetic peripheral neuropathy (DPN). The Diagnostic and Therapeutic Consensus for Diabetic Peripheral Neuropathy recommends metacobalamin for the treatment of DPN neurotrophic repair. The incidence rate of DPN among diabetes patients is as high as 60%, which is a very common chronic complication of diabetes. According to the latest report of IDF, China had about 140 million diabetes patients in 2021, according to this calculation, there are about 84 million patients with DPN in China. Mecobalamin tablet are a Category B drug under the National Reimbursement Drug List (2022 Edition). According to IMS data, the procurement of mecobalamin tablets by China sample hospitals in 2022 exceeded RMB 1 billion. With the growth of the diabetes market, mecobalamin is expected to further expand. Aankondiging • Jan 21
Sihuan Pharmaceutical Holdings Group Ltd. Provides Consolidated Earnings Guidance for the Year Ended 31 December 2022 Sihuan Pharmaceutical Holdings Group Ltd. provided consolidated earnings guidance for the year ended 31 December 2022. For the year, the Group is expected to record a year-on-year decrease in the revenue of not less than 25% for the year as compared with that of the year ended 31 December 2021. The decrease in the revenue of the Group was attributable to a combination of various factors, including primarily the impact of policy changes in the pharmaceutical industry on the Group's sales of pharmaceutical products, macroeconomic downward pressures, disruptions in the supply chain as a result of global geopolitical conflicts, and the impact of the continuing COVID-19 epidemic and response measures on the Company's production, operation and R&D projects. The Group expects to incur a loss of not more than RMB 2,600 million for the year. 
