– Dorzagliatin (trade name: HuaTangNing, world’s first dual-acting glucokinase activator (GKA), successfully entered China’s National Reimbursement Drug List for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (the “NRDL”) at the end of 2023. Hua Medicine worked with sales promotion partner Bayer Healthcare Company Limited (“Bayer”) and 80 Tier 1 distributors to begin the pharmaceutical market entry in 31 municipalities and provinces in China.
– The new NRDL became effective on January 1, 2024. In the first half of 2024, the sales volume of dorzagliatin increased significantly. As of June 30, 2024, sales of HuaTangNing reached 846,000 packs with a sales revenue of RMB102.7 million. The sales revenue increased by 46%, compared with the six months ended June 30, 2023.
– Dorzagliatin experienced a fast entry into hospitals, especially in Shanghai, Beijing, Tianjin where the government policies support market entry for novel new drugs. By the end of June 30, 2024, dorzagliatin was prescribed in over 2,100 hospitals and over 2,900 pharmacies. Dorzagliatin was sold principally through hospitals (approximately 72% of total sales), with the remainder of sales through pharmacies (20%) and internet drug stores (8%).
– Gross profit in the first half of 2024 is RMB47.8 million, representing a gross profit margin of 46.5%. Bank balances and cash position increased by 51.9% to approximately RMB1,338.8 million for the six months ended June 30, 2024, compared with the six months ended June 30, 2023.
– Dorzagliatin manufacturing capacity continues to expand, with the expectation to reach 3 million packs in 2024. New processes for larger capacity have been established with our partners and are under regulatory review for production permit.
– Post marketing clinical studies proceeded at an accelerated rate, in which HMM0601 enrolled 1,368 patients and HMM0701 enrolled 102 patients. HMM0601 is designed to evaluate the long-term safety of dorzagliatin by collecting 1-year clinical safety data in 2,000 T2D patients and HMM0701 is a prospective real-world study to explore dorzagliatin’s clinical beneficial effects on the improvement of glucose homeostasis, cognitive function and diabetes remission. A good drug safety profile for dorzagliatin has been observed since its commercial launch in October 2022 – a time span of over 20 months and approximately 100,000 patient exposure.
– Two Mendelian randomization studies conducted by our collaborating Hong Kong-based clinical investigators, and published in Cardiovascular Diabetology showed that glucokinase activation can lead to long term benefits in reduction of risks in cardiovascular diseases and dyslipidaemia. New clinical indications shall be further explored with our commercialization partner.
Hua Medicine (the Company, HKG: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2024 (the Reporting Period), and the Company’s business progress for the first half of the year and business outlook.
Dr. Li Chen, the founder and CEO of Hua Medicine, said, “The first half of 2024 marks a milestone for the commercialization efforts of Hua Medicine. Dorzagliatin’s successful inclusion in China’s National Reimbursement Drug List has significantly improved patient accessibility and affordability. Against the backdrop of comprehensive support from the national and local governments for the development of the biopharmaceutical industry, and with the joint efforts of the Company, commercial partners, and production partners, the production capacity of dorzagliatin is rapidly increasing, accelerating its entry into hospitals and pharmacies nationwide to benefit more patients. With the continued growth in the number of users, the safety of dorzagliatin has been well validated, and its economic and social benefits have also greatly increased, instilling confidence in the Company’s future development. Through sales expansion and operational optimization, we hope to achieve profitability for the Company by 2025. Currently, Hua Medicine is also conducting basic and clinical research on dorzagliatin globally, aiming to continuously expand its indications and target populations, explore new disease areas, and promote human health and well-being.”
Progress of Clinical Research and Company Operations
– During the first reporting period under the NRDL, dorzagliatin experienced a fast entry into hospital and pharmacies, especially in Shanghai, Beijing, Tianjin where the government policies support market entry for novel new drugs. The number of hospitals prescribing dorzagliatin exceeded 2,100 in the first half of 2024.
– Revenue of dorzagliatin reached RMB102.7 million in the first half of 2024 and is expected to continue to grow in the second half of 2024. As we build off our new foundation under the NRDL, we plan to leverage our well-established partnerships to enhance the dorzagliatin manufacturing process, which is expected to lead to efficiencies, expanded capacity and reduction of cost of goods.
– We continued our post marketing clinical studies at approximately 80 hospitals to better understand the benefits dorzagliatin provides to patients with Type 2 diabetes and T2D complications, such as memory loss and diabetes kidney disease. Through our collaboration with our clinical research partners in Hong Kong, we have discovered that glucokinase (GK) activation may bring the benefits of reduction of risks in cardiovascular disease, and dyslipidemia. These results (applying the Mendelian Randomization (MR) methodology) certainly expand our understanding of the benefits of GK activation through dorzagliatin and for uncovering new indications of dorzagliatin in the future. Mendelian Randomization (MR) is a statistical method that uses genetic variants to investigate the causal effects of exposures (e.g., treatments) on outcomes (e.g., diseases). Its unique advantage lies in its reduced susceptibility to confounding and time-related biases compared with observational studies, which is achieved by leveraging the random allocation of genetic variants at conception. In evidence-based medicine, the credibility of evidence from MR is considered to be among the highest, second only to that of randomized controlled trials.
– We have advanced our post-marketing real world evidence (RWE) studies HMM0601 and HMM0701 in T2D patients in China, and HMM0123 in Hong Kong, China. In these studies, we are collecting evidence in medical practices for optimization of glucose homeostasis either through dorzagliatin alone or in combination with standard care T2D medications such as metformin, DPP-IV inhibitors, SGLT-2 inhibitors, GLP-1RA and insulin. These results create new evidence for dorzagliatin in the expansion of its indication in diabetes prevention and remission.
– We are continuing our drug development pipeline with focus on the fixed dose combination (FDC) of new drug candidates. The new drug Dorzagliatin-Metformin FDC entered manufacturing process validation and our plan is to launch this new medicine for Type 2 diabetes in 2028. Additional new FDC drugs with dorzagliatin will be developed for T2D patients, tailored specifically to address T2D patients with associated complications such as obesity and diabetes kidney disease.
– To further leverage the unique advantage of dorzagliatin in restoring GLP-1 secretion in patients with diabetes and obesity, Hua Medicine initiated its Phase I study in the United States with our 2nd generation GKA. The trial has been proceeding smoothly and has already completed dose escalation in three cohorts of T2D patients in the United States. The topline data is expected to be available in the fourth quarter of 2024, supporting future drug development.
– At the American Diabetes Association (ADA) Annual Meeting 2024, Hua Medicine reported new scientific data supporting the combination of dorzagliatin with a SGLT-2 inhibitor which led to improvement in glycaemic control. Combination of dorzagliatin with chronic kidney disease (CKD) medicine, such as SGLT-2 inhibitor, empagliflozin, in mid to late stage diabetes kidney disease patients, offers new opportunity to expand dorzagliatin’s indication.
– We are exploring more drug repurposing opportunities for dorzagliatin using MR framework, such as renal diseases, neuropathy related diseases, eye related diseases, cognitive disorders, and cancers. Animal studies shall be further performed to validate the promising findings.
– We are continuing to optimize our protein allosteric modulation technology (PAMT) and expansion from positive allosteric modulator (PAM), such as GK positive allosteric modulator dorzagliatin, to negative allosteric modulator (NAM) in kinase and G-protein-coupled receptors (GPCR) proteins. The GK NAM program advanced to the pre-clinical candidate (PCC) selection stage and final optimization of the PCC to clinical candidate for congenital hyperinsulinism (CHI), and potentially for dyslipidaemia. We continue to advance mGLUR5 NAM program for its clinical potential in Parkinson’s disease (PDLID), Fragile X syndrome (FXS), and drug addiction.
Financial highlights
As of June 30, 2024,
– Bank balances and cash position was approximately RMB1,338.8 million.
– Total revenue generated by the Company was approximately RMB102.7 million, reflecting sales of approximately 846,000 packs of HuaTangNing .
– Total other income was approximately RMB55.1 million, of which approximately RMB47.8 million was attributable to the amortization of Bayer milestone income.
– Total expenditures was approximately RMB245.9 million, of which approximately RMB119.8 million was attributable to research and development expenses.
Forward-looking Statement
This article contains the statements regarding the future expectations, plans and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties, or other legal requirements.
About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin on hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.
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