HONG KONG, Aug 25, 2023 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the "Period").

Development Highlights
— In the second quarter, the Group capitalized on the post-COVID recovery, vigorously developed its four therapeutic areas, namely oncology, liver disease, respiratory system and surgery/analgesia, and accelerated the launch of innovative products. During the period, the revenue of the Group in Q2 was up 30.0% and the adjusted non-HKFRS profit attributable to the owners of the parent saw an increase of approximately 20.7% over the same period last year.

— The Group launched a number of new products and achieved considerable sales growth from products in the fields of liver disease and respiratory system. In the first half of 2023, two innovative products were launched to market and two biosimilar drugs received marketing approval. Revenue from liver disease drugs increased by approximately 14.0% and revenue from respiratory system drugs increased by approximately 11.2% compared to the same period last year

— As of 30 June 2023, the Group had a total of 46 innovative drug candidates in the field of oncology, 8 innovative drug candidates related to the respiratory system, 7 innovative drug candidates related to liver disease, and 4 innovative drug candidates in the field of surgery/analgesia in the process of clinical trial application or above. Of these, 3 innovative oncology drug candidates and 1 innovative respiratory system drug candidate are in the marketing application stage, and 4 innovative oncology drug candidates, 1 innovative liver disease drug candidate, and 2 innovative surgery/analgesia drug candidates are in Phase III clinical trials. In addition, the Group had a total of 14 biosimilar or generic drug oncology candidates, 3 additional biosimilar or generic liver disease drug candidates, 13 biosimilar or generic respiratory system drug candidates, and 13 biosimilar or generic surgical/analgesic drug candidates in the clinical trial application or above.

— A marketing application has been submitted to the Center for Drug Evaluation ("CDE") of NMPA for Focus V (Anlotinib hydrochloride capsules) in combination with TQB2450 (Anti PD-L1) for treating first-line small cell lung cancer in January 2023. In addition, 12 new indications for Anlotinib have entered Phase III clinical trials with marketing applications expected to be submitted within the next one to two years.

— Annike (Penpulimab monoclonal antibody) injection was approved in January 2023 for treating, in combination with chemotherapy, first-line locally advanced or metastatic squamous non-small cell lung cancer. In addition, it has another indication (third-line nasopharyngeal carcinoma) going through marketing review.

— Yilishu (Efbemalenograstim alpha) injection was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs. The efficacy and safety of Yilishu, as well as its innovative mechanism, were verified in three pivotal, multi-center, randomized and controlled Phase III studies conducted worldwide, which compared the efficacy and safety of Yilishu with those of drugs commonly used in clinical practice.

— Kailitong (Limaprost) tablets was approved for marketing in February 2023. It is the first drug in China to address the pathological mechanism of lumbar spinal stenosis and has the dual effect of improving neurological microcirculation and neurological functions. And it is the only small-molecule drug specifying in its package insert that it is for the treatment indication of lumbar spinal stenosis. With the launch of Kailitong, a brand-new solution is available to more than 30 million lumbar spinal stenosis patients in China, helping address a huge yet unmet clinical need.

— The clinical trial application of Lanifibranor was submitted to and accepted by CDE in March 2023. In July, Lanifibranor was included on the "Breakthrough Therapy Designation" list by CDE. The product is currently undergoing Phase III clinical trials globally, and is the first oral drug for NASH to enter Phase III clinical trials in China. It is expected to address unmet needs in the China NASH market.

— TDI01(a highly selective inhibitor of ROCK2) is currently in a Phase II clinical development trial. In April 2023, a Phase II clinical trial of TDI01 for the treatment of idiopathic pulmonary fibrosis was initiated in China. Seeing the potential of TDI01 to become a major drug, the Group will vigorously pursue its clinical development.

— All of the Group's generic drugs with annual revenue of more than RMB500 million (excluding exclusive products) entered the centralized procurement list, thus are cleared of further centralized procurement risks.

During the Period, the Group recorded revenue of approximately RMB15.28 billion, a year-on-year increase of approximately 0.5%. Revenue for the second quarter amounted to approximately RMB8.63 billion, representing a YOY increase of approximately 30.0%. Profit attributable to owners of the parent company was approximately RMB1.26 billion. Earnings per share attributable to owners of the parent company were approximately RMB6.78 cents. Adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.48 billion, a YOY increase of approximately 1.2%. Adjusted non-HKFRS profit attributable to the owners of the parent for the second quarter was approximately RMB964 million, representing a YOY increase of approximately 20.7%. The Group's liquidity remains strong, with cash and bank balances classified as current assets of approximately RMB11.58 billion, bank deposits classified as non-current assets of approximately RMB4.23 billion, and wealth management products of approximately RMB3.81 billion in total, and total fund reserves amounting to approximately RMB19.61 billion at the end of the Period.

The Board of Directors has recommended an interim dividend payment of HK2 cents per share (1H2022: HK6 cents).

Sales: The continuous manifestation of R&D achievements has led to outstanding performance in specialty therapeutic products
The Group has benefited from years of in-depth research and development and continues to focus on the development of related products in specialty therapeutic areas with the aim of building its specialty brand.

During the Period, sales of oncology drugs amounted to approximately RMB4.49 billion, accounting for approximately 29.4% of the Group's revenue. Sales of liver disease drugs increased by approximately 14.0% year-on-year to approximately RMB2.29 billion, accounting for approximately 15.0% of the Group's revenue. Sales of surgical/analgesic medications amounted to approximately RMB2.33 billion, accounting for approximately 15.3% of the Group's revenue. In addition, the sales contributions of products in various areas such as respiratory system, cardio-cerebral vascular medicines and others increased simultaneously, accounting for approximately 11.0%, 10.5%, and 18.8% of the Group's total revenue, respectively.

In the field of liver disease, the Group endeavored to strengthen academic promotion of the drugs' efficacy and safety advantages to doctors for the treatment of chronic viral hepatitis, acute drug-related liver injury and liver function abnormalities. Academic conferences at various levels helped to expand the doctor audience and increase the drugs' among experts. Through these activities, the Group was able to actively target new patients and new markets, further driving the rapid sales growth of Tianqing Ganmei.

In the field of surgery/analgesia, the Group focused on hospital access and development in high-potential areas to expand market coverage and hospital channels, strengthening downstream development and improving the development and coverage of secondary hospitals and community healthcare facilities, which has driven the sales of Zepolas (Flurbiprofen) cataplasms to continue to grow with momentum in recent years.

R&D: Strong in-house research and development capabilities, continued focus on R&D of innovative medicines
The Group has continued to focus its R&D efforts on new medicines in four therapeutic areas, namely oncology, liver disease, respiratory system and the surgical/analgesic system. As at the end of the Period, the Group had a total of 127 products under development, including 60 oncology products, 10 liver disease products, 21 respiratory system products, 17 surgical/analgesic products, and 19 products in other categories, of which 69 were Category I innovative products.

The Group will continue to boast strong in-house research and development capabilities and has continued to invest in business development, driving innovation and transformation with its dual-engine approach. During the Period, the Group's R&D expenditure amounted to approximately RMB2.6 billion, accounted for approximately 17.1% of the Group's revenue. Nearly 10 innovative drugs will be launched to market in the next three years, and more than 40 innovative drugs in research and development are expected to be launched by 2030, further strengthening the Group's dominance in its four therapeutic areas and providing strong impetus for long-term sustainable growth.

Prospects: Driven by internationalization strategy, aiming to become a world-class innovative pharmaceutical group with revenue of HK$100 billion by 2030
As the pharmaceutical industry is expected to fully recover within the year, the Group will continue to closely monitor market trends and actively optimize its development strategies, making timely adjustments along the entire industrial chain, including procurement, production and marketing, to mitigate the impact of the pandemic. At the same time, it will continue to focus on innovation and development in the four major therapeutic areas of oncology, liver disease, respiratory system, and surgery/ analgesia, and accelerate its international deployment to build a healthier, more diversified, and sustainable revenue system.

Looking ahead, the Group will continue to adhere to its dual-pronged approach of globalization, i.e. bringing global pharmaceutical innovations to China for the benefit of Chinese patients and going global to open up new markets to accelerate the resolution of global unmet clinical needs. The Group aims to generate revenue of up to HK$100 billion by 2030 and become a world-class innovative pharmaceutical group.


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SHANGHAI, CHINA, Aug 25, 2023 – (ACN Newswire) – — First-in-class glucokinase activator (GKA) HuaTangNing (dorzagliatin) was approved in China in September 2022. Since the launch of commercial sales at the end of October 2022 to June 30, 2023, HuaTangNing achieved total sales revenue of RMB87.9 million. For the first half of 2023, approximately 212,000 boxes of HuaTangNing were sold, and Hua Medicine achieved revenues of RMB70.3 million, representing approximately a 299.6% increase in revenue compared with the second half of 2022.

— The Company filed an application to include dorzagliatin in China's National Reimbursement Drug List (NRDL) and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.

— The Company invested into dorzagliatin scale-up manufacturing capabilities at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano upon its successful commercial launch and during the initial out-of-pocket stage of commercialization.

— The Company has advanced the development of 2nd generation of GKA in overseas markets. Our team is preparing an Investigational New Drug (IND) filing in the United States either by year end 2023 or early 2024.

— The Company has discovered additional therapeutic advantages of dorzagliatin in medical care, including the restoration of endogenous GLP-1 secretion, prevention of cognitive dysfunction, better glycemic control in obese patients with diabetes, and diabetes prevention enabled by reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT).

— As of June 30, 2023, our cash balance was RMB881.3 million, representing an increase of approximately 79.6% as of December 31, 2022. The Company received RMB400 million non-refundable milestone payment from Bayer. With additional government funding, our total cash received from Bayer and government funding in the first half of 2023 was RMB402.6 million.

— On August 17, 2023, the Group and Bayer confirmed the achievement of a certain milestone relating to the development of HuaTangNing. Pursuant to the terms of the commercialization agreement between the Group and Bayer, the Group is entitled to receive a milestone payment of RMB800 million from Bayer.

Hua Medicine (the "Company", HKEx: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2023 (the "Reporting Period").

Dr. Li Chen, the founder and CEO of Hua Medicine, said, "the first half of 2023 was a critical stage for Hua Medicine to begin commercialization. Since successful approval and the launch of prescription sales of dorzagliatin, the Company has worked closely with Bayer across the major channels of on-line drug store, retail pharmacies and hospital pharmacies. The result has been substantial growth of sales that is boosting our confidence in faster growth of dorzagliatin in the future."

"As market demand and user numbers increase, we will carry out more real-world studies on dorzagliatin to meet more unmet clinical needs. In addition, Hua Medicine continues to make breakthroughs in exploring new treatment opportunities for dorzagliatin, including a wider range of indications and product pipelines for more countries and regions. Hua Medicine will continue to work with our partners in exploring more paths for the development of first-in-class drugs in China and around the world, and helping people live healthy and fulfilling lives," Dr. Chen said.

Progress of Clinical Research and Company Operations

— In March 2023, the Company published a research paper in Nature Communications. The paper discusses studies which show that through its modulation of the glucose sensor glucokinase (GK) function and by repairing impaired GLP-1 secretion in patients with diabetes and obesity, dorzagliatin is expected to secure a new indication related to endogenous GLP-1. The study further demonstrated that dorzagliatin restored the impaired glucose homeostasis in T2D patients through its action on GK targets located in the pancreas, intestine, and liver. This may offer a more effective way to achieve diabetes remission in obese diabetes patients through a combination of dorzagliatin with a GLP-1 receptor agonist.

— In June 2023, the Company presented the positive effects of dorzagliatin in the prevention of diabetes and memory deterioration in GK rats at the June 2023 American Diabetes Association (ADA) Scientific Sessions. The Company has filed patents in this area and will continue to expand its research into the benefit of dorzagliatin in disease prevention.

— In June 2023, the Company published our results of a prospective SEED-DREAM study in Chinese non-obese diabetes patients in the well-recognized journal, Diabetes, Obesity and Metabolism, in which we have reported a 65% remission probability during 52 weeks in subjects who have improved their TIR (Time-In-Range, a parameter that represents a better homeostasis control) after dorzagliatin treatment. We have further revealed the determinant factors for achieving diabetes remission after dorzagliatin treatment during the SEED study. These factors include a significant improvement of beta cell function and disposition index, reduction of post prandial glucose and significant increase of TIR during the SEED trial. Improvement of TIR is strongly correlated with reducing the risks of various diabetes complications, including heart attack, stroke and renal disease, as well as neurodegenerative disorders.

— The Company has filed its National Reimbursement Drug List (NRDL) application for dorzagliatin in China and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.

— Hua Medicine has worked with its manufacturing partners since the drug approval to manage market needs. We have secured adequate dorzagliatin supply for the 2023 calendar year, and initiated investment into dorzagliatin manufacturing capability at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano after the successful commercialization launch during the initial out-of-pocket stage. The total investment in 2023-2024 for commercial drug manufacturing and capacity expansion is expected to be in the range of RMB400 million.

— The Company is investigating the potential of dorzagliatin in diabetes prevention in a clinical study. After the initiation of the SENSITIZE II study at Chinese University of Hong Kong (CUHK), the Company is developing clinical study plans of reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT) in China. IGT is a primary cause of T2D, and there are approximately 500 million IGT patients worldwide. The main cause of IGT, especially those with impaired post prandial glucose tolerance, is the impairment of early phase insulin secretion in the pancreas and the defect of glucokinase expression in the liver. Mechanistically dorzagliatin has the potential of reversing the condition of the IGT to NGT, and thereby prevent diabetes.

Business outlook

— The Company will continue with our responsibility as market authorization holder (MAH) of dorzagliatin to commercialize dorzagliatin in China with our partner, Bayer, to expand market share in diabetes care, especially among Type 2 diabetes patients with uncontrolled post prandial glucose (PPG) who will benefit from the improvement of beta cell function and time in range (TIR).

— The Company will continue to invest into dorzagliatin manufacturing capability and into expanding our tier-1 distributor network to drive a three-pronged approach to commercialization in China: hospitals, pharmacies, and on-line drug stores.

— The Company is seeking entry into the National Reimbursement Drug List (NRDL), to facilitate the entry into hospitals and increase accessibility by physicians in order to demonstrate dorzagliatin's potential to be a cornerstone treatment for Type 2 diabetes as monotherapy or in combination with other approved antidiabetic drugs.

— The Company is expecting to receive a certain milestone payment from Bayer related to the development of dorzagliatin in the second half of 2023.

— The Company is also advancing development of our second generation glucokinase activator for potential future international expansion including DKD and diseases associated with impaired glucose homeostasis. Currently, we are actively looking for business partners to advance our R&D programs and commercialization to help more patients globally.

— The Company will continue to develop new drug candidates of fixed-dose-combination of dorzagliatin with metformin, sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor). It was found in clinical studies that the combination of dorzagliatin with a DPP-4 inhibitor or SGLT-2 inhibitor improved glycaemic control and beta cell function in patients with diabetes and obesity.

— Additional benefits of dorzagliatin in disease prevention will be further explored in endocrinology and neurodegeneration.

— Progress has been made in glucokinase candidate targeting congenital hyperinsulinism a rare disease in the United States and China. The AI-based lead optimization will help to advance the program and select clinical candidates with joint effort at AscendRare and Hua Medicine. We are also jointly investigating the opportunity of FKI in different diseases areas and developing sensitive IVD methods for clinical detection of fructose, a sugar component, which contributes to obesity and liver disease. Reduction of the fructose flux into liver could prevent the fatty liver disease and related complications.

Financial highlights

As of June 30, 2023,
— Since the launch of commercial sales at the end of October 2022, dorzagliatin achieved total sales revenue of RMB87.9 million as of June 30, 2023. The revenue of Hua Medicine for the first half of 2023 was RMB70.3 million, which was an increase of approximately 299.6% comparing to the second half of 2022.

— Bank balances and cash position were approximately RMB881.3 million.

— Total expenditures incurred by the Company for the six months ended June 30, 2023, were approximately RMB181.5 million, of which approximately RMB71 million was attributable to research and development expenses.

— Total comprehensive expenses for the period decreased by approximately RMB14.0 million or approximately 13.4% to approximately RMB90.5 million, compared with the six months ended June 30, 2022.

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, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. As Hua Medicine's cornerstone product (dorzagliatin tablets), targeting the glucose sensor, glucokinase, restores glucose sensitivity in T2D patients and stabilizes the imbalance of blood glucose levels in patients, it has been approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families. HuaTangNing has also demonstrated its potential of achieving diabetes remission in clinical studies to help millions of diabetic patients around the world.

Disclaimer

For the accuracy and completeness of the context, references to information related to products launched in China, especially label or requirements, should follow the relevant documents approved by the Chinese regulatory authorities.

The above information should not be interpreted as a recommendation or promotion of any drug or treatment regimen, nor should it substitute for the medical advice of any healthcare professional. Please consult a healthcare professional for any matters related to medical treatment.


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