NEWS DETAIL

  • Source : Press Release
  • Date : 2019-01-11
  • Event type : Phase 3

Sihuan Pharmaceutical's First Anti-Diabetic Innovative Patented New Drug Janagliflozin Commenced Phase III Clinical Trial

Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) (“Sihuan Pharmaceutical” or the “Group”), the largest cardio-cerebral vascular (“CCV”) drug manufacturer in China’s prescription drug market, announced that Janagliflozin (the “New Drug”) has commenced Phase III clinical trial in China (“the Study”). Janagliflozin is the Company’s first Category 1 New Drug to enter Phase III clinical trial stage. This New Drug has acquired patents in China, United States, Europe, Japan and Korea. The market for SGLT-2 inhibitors in both China and abroad is massive. The fact that SGLT-2 inhibitors have entered Phase 3 clinical trials demonstrates that the Company has made significant break-through in self-driven research and development of anti-diabetic drugs. The Company hopes that Janagliflozin will be amongst the country’s top two domestically-produced SGLT-2 inhibitors on the market.

Janagliflozin was developed under pharmacometrics framework, it is the first case to domestically employ SGLT-2 Inhibitors Quantitative Pharmacologic Model to successfully assist the selection of clinical dosages. Janagliflozin has already completed multiple clinical trials involving both healthy volunteers and patients with Type 2 Diabetes. The results so far indicate that the New Drug is safe with a strong and clear dosage-efficacy relationship. The New Drug also features a long half-life, good bioavailability, convenience (oral regiment once a day), and is not easily affected by food consumption — all factors that primarily indicate a robust clinical efficacy. Currently, two subsequent Phase III clinical research trials are expected to be launched. The two trials will evaluate the safety and efficacy of Janagliflozin monotherapy, and Janagliflozin-Metformin combined regiment, respectively, on patients diagnosed with T2DM. Professor Ji Linong from Peking University People’s Hospital will lead the clinical trials, and approximately 60 research sites across China will be involved.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, “in the past 10 years, Sihuan Pharmaceutical has been dedicated in driving the progress of R&D and building an integrated platform, and we are beginning to reap fruit of our continuous efforts. The fact that SGLT-2 inhibitors have entered Phase 3 clinical trials demonstrates that the Company has made significant break-through in self-driven research and development of anti-diabetic drugs. The Company hopes that Janagliflozin will be amongst the country’s top two domestically-produced SGLT-2 inhibitors on the market. SGLT-2 inhibitors can be taken as monotherapy or in combination with other anti-diabetic agents. The market for SGLT-2 inhibitors in both China and abroad is massive. Based on the report published by EvaluatePharma, market sales generated from SGLT-2 inhibitors will reach USD13.3 billion by 2022, making it the best-selling oral medicine for diabetes and the third largest treatment for diabetes, surpassing DPP-4 inhibitors.”

According to the International Diabetes Federation, the adult population suffering from diabetes is expected to reach 628 million globally by 2045. China was estimated to have 114 million (ages 20 to 79) patients with diabetes in 2017, which ranked number 1 in the world. According to Mordor Intelligence, the global diabetes treatment market size in 2017 reached USD56.1 billion, and is expected to grow at a CAGR of 6.25% from 2018 to 2023. China’s diabetes market size, as predicted by Frost & Sullivan, will reach RMB173.9 billion in 2028, steadily growing from RMB51.2 billion in 2017.

Dr. Che said, “The Company’s Metformin Hydrochloride Tablets is the first generic drug that has passed bioequivalence test via supplementary application declaration process. The Company’s long-acting Insulin Degludec and rapid-acting Insulin Aspart have both received approval for, and have already initiated, clinical trials. Having a diverse products line of anti-diabetic drugs will help the Company to advance rapidly in this field and establish a firm foundation for a comprehensive anti-diabetic platform.”
Dr. Che continued, “Sihuan Pharmaceutical’s 3 other innovative drugs, including Oncology Drug Pirotinib, Digestive System Drug Anaprazole Sodium Commenced and Carbapenem Antibiotic Benapenem, are expected to commence Phase III clinical trial in 2019, and to submit the New Drug Application (“NDA”) in 2021. Looking ahead, Sihuan Pharmaceutical has in place a clear set of strategies to promote the Group’s overall capabilities, with the aim to ‘strengthen R&D capabilities, optimize product resources and accelerate market expansion’, and is prepared for the next stage of development.”

SGLT-2 inhibitors are a new pharmacotherapeutic class for the treatment of Type 2 Diabetes Mellitus (abbreviated “T2DM”). They work by reducing the re-absorption of glucose via the kidneys so that the excess glucose is excreted through urination, thus lowering overall glucose levels in the blood. Compared with conventional anti-diabetic agents, SGLT-2 inhibitors exhibit some specific advantages that include a long-acting effect, low risk of hypoglycemia, weight reduction, and convenience (taken orally once a day). Significantly, based on recently released data, SGLT-2 inhibitors have demonstrated beneficial effects of reducing the risks of cardiovascular and kidney diseases in patients with T2DM, potentially ushering in the new era of treatment for patients with diabetes.

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About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. has become the largest cardio-cerebral vascular drug manufacturer in China’s prescription drug market by market share since 2007. Sihuan Pharmaceutical is an integrated corporate with its own production, R&D and marketing capacities. The success of the Group can be attributed to its differentiated and proven sales and marketing model, extensive nationwide distribution network, diversified product portfolio, and strong R&D capabilities. The Group’s current products encompass the top five medical therapeutic areas in China: cardio-cerebral vascular system, central nervous system, metabolism, oncology and anti-infectives. The Group has begun its innovative drug R&D since 2008 and now possesses a well-established innovative drug R&D platform, which is supported by close to 600 R&D experts and focuses in therapeutic areas with considerable unmet clinical demand, including CCV, oncology, diabetes, non-alcoholic liver diseases and pain relief.