The first domestically approved

Time Posted：2020-02-20 21:53

On September 27, 2023, Health Yuan's subsidiary, Shenzhen Tai Tai Pharmaceutical Co., Ltd., obtained approval from the National Medical Products Administration (NMPA) for its new Class 3 registration application of levalbuterol hydrochloride nebulization solution, becoming the first levalbuterol preparation (trade name: Lishutong) to be launched in China. The incidence of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) in China continues to increase, with patients accounting for as much as one-tenth of the total population. However, due to a general lack of patient awareness, the diagnosis and standardized treatment rates remain severely low. Currently, nebulization therapy is a commonly used method of drug administration for patients with respiratory diseases. However, according to IMS data, in 2018, foreign pharmaceutical companies occupied 91% of the Chinese market for nebulization drugs. Due to the high R&D threshold in the field of nebulization preparations, there are almost no better domestic alternatives. Health Yuan's newly approved levalbuterol hydrochloride nebulization solution (Lishutong) is expected to break the deadlock of the nebulization drug market being highly monopolized by foreign pharmaceutical companies, and also provides domestic doctors with more choices in the field of respiratory disease medication. It is worth noting that on June 6, 2018, the list of drug registration applications included in the priority review procedure by the NMPA's Center for Drug Evaluation (CDE) (29th batch) included three pediatric drugs, and Health Yuan's levalbuterol hydrochloride nebulization solution was among them. From the inclusion in the priority review procedure application, it took the NMPA only one year and two months to approve Lishutong for listing, indicating the urgent market demand for the drug and highlighting the profound technical R&D background of Health Yuan's R&D team. Foreign companies monopolize 91% of inhalation preparations. A Ping An Securities research report in June this year stated that chronic respiratory diseases are the third leading cause of death from chronic diseases among Chinese residents: China's chronic disease mortality rate reached 533/100,000 in 2012, with chronic disease deaths accounting for 86.6%, of which the mortality rate from chronic respiratory diseases was 68/100,000, accounting for 12.8%, making it the third leading cause of death from chronic diseases after cardiovascular and cerebrovascular diseases and tumors. According to statistics from the Ministry of Health, the incidence of respiratory diseases in China accounts for about 6.94% of the total incidence, with 150 million people suffering from various respiratory diseases every year. In the face of a patient population of over 100 million, there are few treatment methods, and the treatment drugs are not only limited in variety but are also mainly in the hands of foreign pharmaceutical companies. Asthma, as a chronic inflammatory disease, can be controlled by long-term use of corticosteroids, while the treatment of acute exacerbations of asthma and COPD is centered on bronchodilators, mainly to relieve bronchospasm and improve ventilation, with some overlap in medication. In terms of dosage forms, inhalation dosage forms have gradually become mainstream. According to research reports, the global market size for asthma and COPD drugs exceeded US$45 billion in 2017, with the inhalation preparation market reaching US$37 billion. Blockbuster products have frequently emerged in this field, with the average sales of the top 10 products in the United States in 2017 being around US$2 billion. The report also analyzes that the current domestic market for asthma and COPD drugs is approximately 17 billion yuan, with a CAGR of 14% from 2012 to 2018, of which foreign companies account for 78%, and inhalation dosage forms account for 67%. Among inhalation dosage forms, foreign companies account for 93%, with AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline (GSK) accounting for 91% of the market. For example, Seretide is GSK's best-selling inhaled asthma or COPD drug, but it lost its US patent protection in 2010. Even years after the patent expired, it has not been affected by generic drugs, mainly because Seretide is a combination product of a drug and an inhaler. The production process of this combination product is relatively complex, and it is more challenging to develop than solid oral dosage forms such as tablets. The US FDA only approved the first generic drug for Seretide in February this year. The NMPA has indeed approved many inhalation preparations before, but they were all approved before the implementation of the new chemical drug registration classification. According to information from the Pharmaceutical Cube database, between 2016 and 2018, before the approval of Health Yuan's Shutanlin (inhalation compound ipratropium bromide solution), the NMPA only approved six inhalation preparations for the first time, and all of them were registered under the old Class 6 system. Four of them were inhalation acetylcysteine solutions for expectoration, which still need to undergo consistency evaluation after approval (see: Health Yuan's "inhalation compound ipratropium bromide solution" becomes the first generic drug to be launched, opening up a major change in the domestic inhalation preparation market). Lishutong® accelerates the domestic substitution of inhalation preparations. On April 3, 2018, the General Office of the State Council issued the "Opinions on Reforming and Improving the Supply Guarantee and Use Policies for Generic Drugs" (hereinafter referred to as the "Opinions"), which focuses on three important directions for generic drugs: first, promoting the R&D of generic drugs, focusing on solving the shortage of high-quality generic drugs; second, highlighting problem orientation and improving the quality and efficacy of generic drugs; and third, improving supporting policies and promoting the rapid entry of high-quality generic drugs into clinical use. In fact, the layout of high-quality domestic pharmaceutical companies in the field of high-difficulty generic drugs is far ahead of the current policy support. As early as 2013, Health Yuan Pharmaceutical Group Co., Ltd., relying on its strong technical R&D background, focused on the layout and is committed to becoming a leading brand in the field of respiratory nebulization therapy. Six years later, Health Yuan's layout began to bear fruit. In April this year, it launched the first new Class 4 registered and approved nebulization solution in China—Shutanlin® (inhalation compound ipratropium bromide solution). This is also the first drug in nebulization preparations that is considered to have passed consistency evaluation. At the same time, for the NMPA, this means that the registration and approval path for inhalation solution preparations with higher standards (chemical drug registration classification reform work plan) has been opened up, and the CDE will have more experience in the subsequent approval of varieties. On September 27, Health Yuan launched another first in China—the first new Class 3 registered and approved nebulization solution, Lishutong® (levalbuterol hydrochloride nebulization solution), which also became the first levalbuterol to be launched in China. Compared with ordinary salbutamol, Lishutong® has the characteristics of fewer side effects, better efficacy, and smaller dosage. First, Lishutong® removes the dextrorotatory isomer, which has higher β1 receptor selectivity and can produce side effects; it only contains the levorotatory active ingredient with higher β2 receptor selectivity, resulting in a lower incidence of side effects; second, it improves FEV1 more than salbutamol, promotes symptom improvement, and reduces hospitalization rates; third, 0.63 mg of levalbuterol has the same efficacy as 2.5 mg of salbutamol. The successive launches of Shutanlin® and Lishutong® mean that Health Yuan has the ability to produce high-end generic inhalation preparations, and the monopoly position of imported companies will be broken. Domestic companies such as Health Yuan are actively deploying in blockbuster products, and once the first generic drug is successful, they are expected to quickly achieve import substitution. Regarding the successful launch of Lishutong®, Health Yuan stated: "The company has always used 'Healthy Breathing, Yuan Qi You Wo' as its slogan in the respiratory field. This not only means that Health Yuan will take 'becoming a leading brand in the field of respiratory nebulization preparations' as its vision, but also hopes to produce high-quality domestic drugs, provide Chinese doctors with more and better choices, and allow more asthma and COPD patients to receive better diagnosis and treatment." Source: Pharmaceutical Cube

Leading a new pattern in China's inhalation preparation market: The launch conference for HealthGen's new product "Shutanlin" was grandly held!

Time Posted：2020-02-19 21:59

In China, multinational pharmaceutical giants have long held over 90% of the market for inhalation preparations related to respiratory diseases. This market has always been called the "highest-end and most difficult segment in the generic drug field." This year, Joincare Pharmaceutical Group Industry Co., Ltd.'s "Shutanlin" (compound ipratropium bromide solution for inhalation) was approved for marketing. The launch of "Shutanlin" has milestone significance for the R&D of domestic generic inhalation preparations, and its appearance will lead a new pattern in the domestic inhalation preparation market. On September 6, Joincare Pharmaceutical Group Industry Co., Ltd. (hereinafter referred to as "Healthy Yuan Group") held a grand new product launch satellite meeting themed "Healthy Breathing, Yuan Qi You Wo" at the Wuhan International Conference Center. Professor Huang Mao, director of the Respiratory Department and Respiratory Disease Research Institute of Jiangsu Provincial People's Hospital; Professor Song Yuanlin, director of the Respiratory and Critical Care Medicine Department of Huashan Hospital Affiliated to Fudan University, and doctoral supervisor; and Professor Cui Yongyao, from the Department of Pharmacology, Shanghai Jiao Tong University School of Medicine, attended the meeting and delivered wonderful speeches. As the first inhalation preparation approved by Healthy Yuan Group, the appearance of "Shutanlin" (compound ipratropium bromide solution for inhalation) at this meeting allowed nearly 10,000 respiratory-related clinicians from across the country to learn about this drug, the first in China to pass consistency evaluation and the first new Class 4 registered and approved nebulized inhalation solution, for the first time through the introduction of authoritative experts. It is reported that the launch of "Shutanlin" has milestone significance for the R&D of domestic generic inhalation preparations: Currently, chronic respiratory diseases have become the third leading cause of chronic disease death in China. However, due to the high barriers to R&D, approval, and production of inhalation preparations, this market in China has long been dominated by foreign companies. In order to seize the development opportunities in the respiratory system drug market, Healthy Yuan Group conducted in-depth research in this field, establishing Shanghai Fangyu Healthy Pharmaceutical Technology Co., Ltd., with Professor Jin Fang, a member of the Chinese Pharmacopoeia Commission and former director of the Shanghai Respiratory System Drug Engineering and Technology Research Center of the Shanghai Pharmaceutical Industry Research Institute, at its core. It also jointly established Guangzhou Healthy Yuan Respiratory Drug Engineering and Technology Co., Ltd. with the Guangzhou Institute of Respiratory Diseases, presided over by Academician Zhong Nanshan of the Chinese Academy of Engineering, an expert in respiratory diseases and a medical authority, investing heavily in the R&D of respiratory system drugs and accumulating rich experience in inhalation preparation technology. On April 9 this year, Healthy Yuan Group announced that it had received the "Drug Registration Approval Document" issued by the National Medical Products Administration, and "Shutanlin" (compound ipratropium bromide solution for inhalation) was approved for marketing as a new Class 4 registration application. Previously, only Boehringer Ingelheim's original "Tiotropium" was on sale domestically, and Healthy Yuan Group is the first generic manufacturer. It can be said that the launch of "Shutanlin" meets the needs of many domestic patients to use high-quality domestic drugs. It is worth mentioning that Professor Cui Yongyao from the Department of Pharmacology, Shanghai Jiao Tong University School of Medicine, also introduced another inhalation preparation about to be approved by Healthy Yuan Group at the meeting—"Lishutong" (salbutamol hydrochloride nebulized inhalation solution). It is the first new Class 3 registered and approved nebulized inhalation solution in China, which means that "Lishutong" will also become the first salbutamol to be launched in China. Compared with the imported or domestic salbutamol already on the market in China, "Lishutong" has the characteristics of small dosage, high efficacy, and high safety. This another "first" for Healthy Yuan Group means that it will continue to provide Chinese doctors with more and better choices, benefiting more asthma and chronic obstructive pulmonary disease patients, and also demonstrating Healthy Yuan Group's confidence and strength in the field of inhalation preparations. Currently, Healthy Yuan Group is on the eve of an outbreak in the respiratory inhalation preparation market, and the biopharmaceutical business of its subsidiary Lizhu Group is also experiencing explosive growth. It is believed that after "Shutanlin" and "Lishutong," Healthy Yuan Group will become increasingly stable in the innovation and R&D of inhalation preparations. The series of inhalation preparation products about to be launched in the future are also highly anticipated! Source: Sohu.com

Nearly 40 million yuan invested in R&D; Health Yuan's monoclonal antibody injection approved for clinical trial

Time Posted：2020-02-19 20:07

On February 19, Jiankangyuan issued an announcement stating that its subsidiary, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd. (Lizhu Monoclonal Antibody), and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd. (Xinkanghe Bio) have received approval from the National Medical Products Administration for their jointly submitted clinical trial application for "Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection."

Announcement on the Acceptance of Clinical Trial Application for Drugs by Joincare Pharmaceutical Group Industry Co., Ltd.

Time Posted：2020-02-18 20:14

The board of directors and all directors of this company guarantee that the content of this announcement contains no false records, misleading statements, or major omissions, and assume individual and joint and several liability for the authenticity, accuracy, and completeness of its content.

Joincare Pharmaceutical Group Industry Co., Ltd. Announcement on Obtaining Drug Acceptance Notice

Time Posted：2020-02-18 20:10

Announcement on Obtaining Drug Acceptance Notification Letter The board of directors and all directors of this company guarantee that the content of this announcement does not contain any false records, misleading statements, or major omissions, and assume individual and joint and several liability for the authenticity, accuracy, and completeness of its content.

Healthy Yuan: Plans to repurchase company shares with its own funds ranging from 150 million to 300 million.

Time Posted：2020-02-10 20:16

Lanfu Finance reported on February 10 that Healthy Yuan announced that the company intends to repurchase its shares through centralized bidding using its own funds; the total amount of funds for share repurchase: no less than RMB 150 million (inclusive) and no more than RMB 300 million (inclusive); repurchase price: no more than RMB 15/share (inclusive), repurchase period: within 12 months from the date the company's board of directors approves the share repurchase plan. Repurchase purpose: The repurchased shares will be used for employee stock ownership plans and equity incentives, of which 40% of the repurchased shares will be used for employee stock ownership plans, and 60% will be used for equity incentive plans.

Lizhu Reagent and the Wuhan Institute of Virology, Chinese Academy of Sciences, have successfully developed a rapid colloidal gold antibody detection reagent that produces results within 15 minutes.

Time Posted：2020-02-02 20:27

To accelerate the detection of the novel coronavirus and effectively control the further spread of the epidemic, after Lizhu Reagent jointly developed the Novel Coronavirus IgG/IgM Serological Diagnostic Kit (ELISA) with the Wuhan Institute of Virology, Chinese Academy of Sciences, and independently developed the Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-fluorescence probe method)/(PCR fluorescence method), today it has successfully jointly developed with the Wuhan Institute of Virology, Chinese Academy of Sciences, the Novel Coronavirus IgG/IgM Detection Kit (colloidal gold method), which can produce test results within 15 minutes, racing against the virus to win precious time, and adding another weapon to fight the epidemic. Single-person detection, manual and automated operation can assist primary-level medical institutions in early screening and diagnosis. As epidemic prevention and control enters a critical stage, primary-level medical institutions will become the main battlefield for the discovery and isolation of the epidemic. Currently, primary-level medical institutions lack large-scale testing equipment, making large-scale testing and screening extremely difficult. In the face of the pressure of epidemic prevention and control, the primary level urgently needs the support of a small, lightweight, and rapid testing system. In response to this situation, Lizhu Reagent quickly launched research and development and transformation, and completed the development of the Novel Coronavirus IgG/IgM Rapid Detection Kit (colloidal gold method). Novel Coronavirus IgG/IgM Rapid Detection Kit (colloidal gold method) 1) Sample types can be whole blood/serum/plasma; 2) Manual and automated operation is possible. Applied to the GS1201 rapid detection platform for rapid detection of pathogens in outpatient clinics. Currently, Lizhu Reagent's Novel Coronavirus IgG/IgM Rapid Detection Kit (colloidal gold method) has applied for entry into the fast-track approval process and will soon be launched for use on the front line of epidemic prevention and control, helping to solve the early screening and diagnosis of suspected cases at the primary level and assisting the primary-level battlefield in winning the battle against epidemic prevention and control.

Public Notice on the Completion Acceptance of Environmental Protection for the Upgrading and Transformation Project of 50,000-ton Annual Output of Organic Fertilizer Raw Material Sludge Disposal of Jiaozuo Jiankangyuan Bio-products Co., Ltd.

Time Posted：2020-01-04 20:39

In accordance with the requirements of the "State Council Decision on Amending the Regulations on Environmental Protection Management of Construction Projects" (State Council Order No. 682) and the "Interim Measures for the Acceptance of Environmental Protection upon Completion of Construction Projects" (Guo Huan Gui Huan Ping [2017] No. 4), the main contents of the "Completion Acceptance Monitoring Report on Environmental Protection of the 50,000-ton Annual Output of Organic Fertilizer Raw Material Sludge Disposal and Upgrading and Transformation Project of Jiaozuo Jiankangyuan Bioproducts Co., Ltd." and the acceptance opinions are hereby publicized.