Hualing Pharmaceutical's world's first innovative drug, Glucokinase Activator Huatangin(R), was approved for listing

It is expected to expand the new pattern of type 2 diabetes treatment in China

Shanghai, October 9, 2022 /PRNewswire/ -- Hua Ling Pharmaceutical (the "Company", HKEx Stock Code: 2552.
HK) today announced that the company's world-first (in-class) new drug glucokinase activator (GKA) Huatangin (dogliatin tablets, dorzagliatin ®, HMS5552) has been approved for
marketing by the State Drug Administration of China (NMPA) on October 8.
Hua Donning ® has been approved for two indications, namely the treatment of type 2 diabetes patients who have not been treated with drugs, or the combination of metformin in combination with metformin in the treatment of type 2 diabetes mellitus
in adults when metformin alone is poorly controlled.
For patients with renal insufficiency, no dose adjustment is required, and is an oral hypoglycemic drug
that can be used in patients with type 2 diabetes mellitus with moderate to end-stage renal impairment.
At the same time, clinical trials have shown that the efficacy of the administration of Valtanin ® in combination with empagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-4 inhibitor) is better than that of drug alone, which is expected to better improve blood glucose control and islet function
in patients with type 2 diabetes.

Huadoning ® is the world's first approved glucokinase activator drug, the first original innovative drug in the field of diabetes in the past decade, and the world's first innovative drug
for type 2 diabetes in China.
This milestone represents an important step
forward for China's biomedical industry to use advanced innovative scientific concepts to achieve the clinical needs of Chinese patients.
Huatang Ning ® is the world's first innovative drug developed by Hualing Pharmaceutical using the operating model of "Chinese and Western integration, joint innovation, sharing and win-win", marking a new historical stage
in China's leading pharmaceutical innovation.

Huatang Ning ® is the world's first innovative drug independently developed by Hualing Pharmaceutical adhering to the tenet of "patient first, innovation-oriented, and good medicine for the people", aiming at the disease characteristics of diabetic patients in China
.
Since its inception, Huatangning's ® R&D project has received great attention and attention from the new drug research and development industry and the national drug review and approval department, and has been continuously selected into the "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" major new drug creation projects
of the Ministry of Science and Technology 。 Huadoning ® has new concepts, new mechanisms, new structures, new technologies and new efficacy and other "five new" characteristics, from preclinical experiments, to phase I, II, phase III clinical trials, the process is led by the Chinese R & D team and Chinese clinical researchers, not only to achieve a major R & D breakthrough from innovative concepts to innovative products, but also for China to develop the world's first innovative drug to explore a feasible path
of independent research and development.
The successful approval of Huatangning ® also means that after more than 20 years of development, many pharmaceutical companies at home and abroad have finally ushered in the world's first approved GKA drug, achieving a breakthrough
of zero.
After the approval of the listing, Hua Ling Pharmaceutical will work with Bayer to promote the commercialization of Hua Doning ® in China for the benefit of diabetics and their families
.

Globally, the incidence of diabetes continues to grow
.
According to the latest data from the International Diabetes Federation (IDF), the number of adult diabetics worldwide will reach 537 million in 2021, an increase of 74 million compared with 2019, an increase of 16%.

In 2021, global health spending on diabetes and its complications will be estimated at $966 billion
.
The situation of diabetes prevention and control in China is not optimistic, the number of diabetic patients in 2021 has reached 140 million, of which about 72.
83 million patients have not been diagnosed and treated, the proportion is as high as 51.
7%.

At the same time, the large fluctuations in blood sugar of diabetic patients have led to a series of diabetic complications such as cardiovascular and cerebrovascular diseases, kidney diseases, eye diseases, diabetic feet, etc.
, which greatly affects the survival needs and quality of life of diabetic patients, and brings a heavy disease burden
to patients and their families.
Therefore, improving blood glucose homeostasis in patients with type 2 diabetes and maintaining high TIR (time in range) of patients has become an important goal
of diabetes treatment management.
According to the "14th Five-Year Plan" National Health Planning Notice issued by the General Office of the State Council, improving the comprehensive prevention and treatment capacity of major chronic diseases such as diabetes will continue to be a health issue of national concern, and it is expected that the grass-roots standardized management service rate of type 2 diabetes patients during the "14th Five-Year Plan" period will reach more than
65%.
The successful approval of Hua Doning's ® listing conforms to the national strategy
of China's pharmaceutical industry development and national health improvement.

The rapid growth in the number of diabetics and the huge market capacity for diabetes drugs both point to the unmet medical needs
in the diabetes sector.
According to the original scientific concept of "repairing the sensor, reshaping the steady state, and treating diabetes from the source", Hualing Pharmaceutical has directly attacked the root cause of the blood glucose sensor failure in patients with type 2 diabetes mellitus and successfully developed Huatangin, ® the world's first innovative drug
.
Clinical studies have shown that Huatangin ® can repair the damaged glucokinase sensor function of diabetic patients, improve the patient's ability to autoregulate blood sugar, and is expected to control the progression and complications of type 2 diabetes from the source
.

As a new class of type 2 diabetes treatment drugs, the research and development of Huadoning ® has also received continuous attention
from the international academic community.
In 2018, the results of its Phase II clinical study were published in the international advanced medical journal "The Lancet-Diabetes and Endocrinology", which is the first clinical research results on innovative drugs for type 2 diabetes in China published in the journal; In May this year, the international top medical journal Nature Medicine simultaneously published two peer-reviewed papers on the results of its Phase III study, which detailed and described the clinical findings of single-drug (SEED) and combined metformin (DAWN study) for the treatment of type 2 diabetes, fully affirming that Huatangin, as a new mechanism of diabetes drugs, has significant safety advantages, has the mechanistic characteristics of improving islet function in patients with type 2 diabetes, and points out that Huatangin ® ® Unique advantages
have been shown in clinical trials in patients with diabetic nephropathy.

Other clinical research data also show that Huatanginin in combination with DPP-4 inhibitors, SGLT-2 inhibitors in the control of blood glucose has shown significant synergistic effect, good safety, in different sugar control needs and different disease stages of type 2 diabetes patients with a wide range of application potential, and is expected to restore insulin ® early phase secretion and lasting improvement of β cell function, become an important way to
achieve diabetes remission 。 In the future, Hua Ling Pharmaceutical will continue to explore the potential of Hua Doning ® in the treatment of type 2 diabetes discontinuation and combination with existing 9 types of diabetes drugs, and strive to meet major social needs such as diabetes prevention, mitigation and delay of complications, and promote Chinese innovation to the global market
.

Ms.
Zhou Xiaolan, Global Executive Vice President and President of the Prescription Drugs Division of Bayer Group in China and President of Bayer Group Greater China, said: "Bayer has been deeply involved in the field of diabetes treatment and helped the development of
diabetes prevention and control in China.
Together with Baitangping, the first oral hypoglycemic drug with indications for impaired glucose tolerance (IGT), and the Continuous Glucose ® Monitoring System (CGMs), Huatang Ning ^® will establish a full-course management from prevention to treatment for patients with type 2 diabetes in China and achieve the goal of 'steady-state hypoglycemia' through real-time blood glucose monitoring; Bayer will also actively explore digital solutions to help hundreds of millions of patients in China realize the vision of avoiding diabetes as soon as possible.
"
。 "

Dr.
Chen Li, Founder, CEO and Chief Scientific Officer of Hua Ling Pharmaceutical, said: "The successful approval of Hua Tang Ning ® is a major milestone event for Hua Ling Pharmaceutical and marks a new stage
of development for China's innovative drug industry.
Diabetes chronic disease management is a major strategic issue related to the national economy and people's livelihood, Hualing Pharmaceutical adheres to the original intention of 'China leads pharmaceutical innovation', in the fierce international competition, hard work for 10 years to achieve zero breakthrough, and Hualing researchers and collaborators jointly developed this world's first diabetes new drug
in China.
This is the common result of all Chinese scientists, clinicians and collaborators involved in ® Huatangin's research and development, and we are very proud of Huadoning's approval of the listing, and we are very grateful to all of us for their hard work and dedication
to the approved listing of Huatangin ® ®.
At the same time, Hua Ling Pharmaceutical expects to deeply integrate with Bayer and fully open up its vitality, comprehensively accelerate the commercialization process of Hua Doning ®, bring new hope for diabetes prevention, treatment and alleviation to hundreds of millions of diabetic patients in China, improve the standards of diabetes prevention and treatment, and contribute to the realization of the national strategy of Healthy China 2030
.
"

About Hua Doning®

Huatangin (Dopagliptin Tablets) is a world-first, new mechanism, ectopic allosteric function of glucokinase activator for use alone or, in combination with metformin hydrochloride in combination with diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus when metformin ® hydrochloride glycemic control
is poor 。 Hua Donning ® is expected to achieve a target multi-point, coordinated sugar control by repairing the damaged glucokinase function of the pancreas-gut-liver, which can regulate the secretion of the glycemic hormones insulin, GLP-1 and glucagon in blood glucose-dependent manner, improve the early phase secretion and disposal index of insulin in diabetic patients, and restore blood glucose homeostasis and achieve the potential
of diabetes discontinuation and relief.
In two phase III registered clinical studies of monotherapy and combination with metformin, Hua Donning ® showed significant hypoglycemic effects in subjects, which can effectively reduce postprandial blood glucose, and the risk of hypoglycemia is low and the safety tolerance is good
.
Huatangin ® has a good linear relationship between drug dose and blood exposure, the target organ is distributed in the pancreas, intestine, liver, kidney excretion is low, the pharmacokinetic characteristics are similar in patients with end-stage renal disease (ESRD) and healthy subjects, and patients with renal insufficiency do not need to adjust the dose
.
Huatangin's ® unique mechanism of action, good pharmacokinetic characteristics and good safety and tolerance make it a new class of diabetes treatment drugs
.

About Hua Ling

Hua Ling Pharmaceutical is an innovative drug discovery company founded in China, focusing on unmet medical needs and developing new therapies
for patients around the world.
Hua Ling Pharmaceutical brings together high-quality talents in the global pharmaceutical industry, integrates global innovative technologies, relies on global superior resources, researches and develops breakthrough technologies and products, and leads global diabetes medical innovation
.
Its core product Hua Doning ® (Dopaglidine Tablets) targets glucokinase with glucose sensor glucokinase as the target, improves glucose sensitivity in patients with type 2 diabetes, completes two phase III registered trials of sowing research (SEED) and dawn research (DAWN) in China, and has officially obtained the new drug marketing approval of the State Drug Administration (NMPA) of
China.
This world-first glucokinase activator has demonstrated the potential of diabetes remission in clinical studies to help hundreds of millions of diabetic patients worldwide
.

About Bayer

As a global company, Bayer has core competencies
in health and agriculture in the life sciences sector.
Through products and services, the company is committed to helping people overcome the major challenges posed by the growing global population and ageing for the benefit of people and the planet
.
Bayer is committed to driving sustainability and having a positive impact on
the business.
At the same time, the Group also enhances profitability and creates value
through technological innovation and business growth.
Worldwide, the Bayer brand stands for trustworthiness, reliability and quality
.
In fiscal 2020, Bayer employed approximately 100,000 people and generated sales of EUR
41.
4 billion.
R&D investment excluding special projects is EUR
4.
9 billion.
See www.
bayer.
com
for more information.

About the cooperation between Hua Ling and Bayer

In August 2020, Bayer, a multinational pharmaceutical company, and Hua Ling Pharmaceutical, an innovative drug research and development company in China, announced the establishment of a strategic cooperation in
China on the new and pioneering diabetes treatment drug dopagliptin.
The collaboration aims to leverage Bayer's deep strengths in diabetes management in China and Hua LingPharma's R&D expertise in diabetes to provide new treatment options for the benefit of hundreds of millions of diabetic patients
in China.
According to the cooperation agreement, Hua Ling Pharmaceutical, as the holder of the drug marketing authorization, will be responsible for clinical research, drug registration, drug supply and distribution; Bayer, as the promotion service provider, will be responsible for the marketing, promotion and medical education activities of the product in China
.
The Bayer Prescription Drugs China Co-Innovation Center led to the collaboration
.
As a global leader in medicine, Bayer is committed to working with external partners to drive breakthrough innovations, bring positive changes to patient health, and achieve the goal
of "collaborative innovation, joint cure".