Establishing a “dual circulation” development pattern that based on Domestic market, aiming at International market, both markets interact and promote on each other.
Recently, both Tinidazole tablets and Gliquidone tablets from Yiling Group have passed generic quality consistency evaluation, this means currently Yiling Group have 11 products passed this consistency evaluation, which indicates drug quality is not lower than branded drug and have equivalent efficacy to branded drug.
When it comes to Yiling Group, we are familiar with Lianhua Qingwen, a traditional Chinese medicine(TCM) that plays an important role in COVID-19 in the past two years.But in fact, TCM is only one of Yiling’s three major business sectors.In recent years, Yiling Group has rapidly developed TCM, meanwhile actively laid out chemical&bio-medicines and health industry, and has constructed a medical and health industry with coordinated development and mutual promotion of three sectors with patented TCM, chemical&bio-medicines and health industry. The chemical&bio-medicines sector has made outstanding achievements in recent years, formulating a developmental strategy that is “Cutting-in by Contract Manufacturing – accelerating International and Domestic dual registration of generic drugs- Promoting the R&D, production and sales of innovative drug”. It has cultivated a high-level production, technology, quality and sales management team proficient in EU and US GMP management, and has marketed excellent products at home and abroad.
Cutting-In by Contract Manufacturing:
Build a platform in line with EU and US GMP standards and lay a foundation for internationalization.
The goal of the first step strategic planning of chemical&bio-medicines sector of Yiling Group is to “Cutting-in by Contract Manufacturing”, that is building production workshops and quality management system in accordance with EU and US GMP standards,to carry out manufacture and export of Finished Drug Products for domestic and international enterprises, including pharmaceutical R&D institutions, large pharmaceutical enterprises and pharmaceutical commercial companies (MAH holders). Yiling Pharmaceutical Ltd. (hereinafter referred to as”Yiling Pharma”) is a wholly owned subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd.(hereinafter referred to as”Yiling Group”), undertakes the development business of the international and domestic markets of chemical&bio-medicines.
At present, the first goal of Yiling Pharma has achieved. Yiling pharma has two production sites, located in Shijiazhuang and Beijing Miyun. Both sites have passed multiple GMP inspections conducted by US FDA, EU and other authorities. The latest US FDA inspection was carried out on April 2022, and Yiling Pharma approved very successfully. Shijiazhuang site could have multiple production line for general tablets and capsules, and Beijing Miyun site could produce anti-cancer and high-potent drugs. Multiple products manufactured by Yiling Pharma have been launched in PIC/S member countries, which also shows that Yiling pharma’s quality management system has been recognized in the international market. Yiling pharma will continue to optimize capacity and pipelines to promote markets diversification and further increase gross profit margin.
At the same time, Yiling Pharma has also carried out a differentiated business positioning according to the market and the company’s development needs.Taking advantage of the integration of chemical drug R&D, production and sales, Yiling pharma engages in the pharmaceutical research and development, clinical trial processing, commercial production and marketing of innovative drugs and improved new drugs from domestic and foreign pharmaceutical R&D institutions, production enterprises and commercial companies. At present, it has cooperated with a number of companies on multiple first-class new drugs and sustained and controlled release preparations. Yiling Pharma has repeatedly been awarded the title of “Representative Enterprise for the Processing of Clinical Samples of New Drugs in China” issued by industry organizations, and its brand and industry influence have gradually expanded.
International and domestic dual registration of generic drugs:
Break Through Technology Barrier, and Realize A “Dual Circulation” development Pattern in Products Distribution.
The second target strategic planning of Yiling pharma is “international and domestic dual registration of generic drugs”. The goal of the second stage is to designate generic drugs with large market capacity, growth potential and high technical threshold, to finishe R&D and registration in domestic and high-end international markets. While achieving the sales in international markets such as Europe and US, the domestic varieties sales activities shall be carried out by using the throughout marketing network in China. At present, the second strategic plan is developing in depth.
For the US market, Yiling Pharma has 13 ANDA products approved by US FDA, including 12 self-developed and 1 outsourced product, and commercial production and sales are steadily advancing.
For the domestic market, Yiling Pharma uses the priority review policy of “European and American collinear production” application to transfer 5 ANDA products approved by US FDA to China, of which 4 products have been included in the priority review procedure and 1 product has been approved.
In addition to domestic and international market planning, Yiling Pharma timely adjusts its R & D direction according to market changes, transformations from general generic drugs to the first generic drugs, sustained and controlled release drugs with high technical barriers and other high-end generic drugs, and further improves its own products’ competitiveness.
In order to cope with the impact of national centralized procurement of generic drug, Yiling Pharma continues to give full play to the advantages of large-scale manufacturing costs, improves the construction of entire industry chain, and builds a new API R&D and production site – Wanyang Hengshui Pharmaceutical Co., Ltd. Wanyang Site is designed and constructed in accordance with the requirements of US FDA and EU cGMP, and equipment required for production implement international and domestic first-class standards. Aiming at R&D and production of featured high-end APIs, bulk drug substance with huge market demands, supporting APIs for Yiling own drugs and APIs for innovative drugs, Wanyang focuses on the fields of cardiovascular, respiratory, digestive, oncology and antiviral diseases, currently it’s running 31 APIs, including 17 APIs for downstream production for finished production to ensure own drugs, and timely entering the APIs international market.
R&D, Production and Sales of Innovative Drugs：
Strong R&D team and thorough sales network promote the development of chemical drugs in depth.
The third target of development strategy is, through the R&D of innovative drugs, then conducting domestic and international registration and patent authorization in foreign markets, to make Yiling Pharma be a large multinational pharmaceutical enterprise with the core competitiveness of innovative drugs and advanced technology platform , At present, 27 products have been approved by China NMPA and US FDA, including 11 products passed generic quality consistency evaluation.
In terms of R&D, Yiling Group attaches great importance to independent R&D activity of innovative chemical drugs, and will continue to speed up screening and approval of new projects, enrich pipelines, and improve product layout on the basis of current achievement of new drug R&D. In cardiovascular and other key areas, Yiling Group has following projects steadily advancing: 4 innovative drugs in the clinical stage, 1 innovative drug in the pre-clinical stage, and several innovative drugs in the screening and drug resistance evaluatioaddition to innovative drugs, Yiling Group also strengthens the layout of high-end improved new drugs, including long-acting release preparations, transdermal preparations and inhalation preparations, covering the fields of respiratory diseases, cardiovascular diseases, diabetes, cancer and reproductive diseases.
Based on a strong R&D team and full equipped facilities, taking a high starting point, high standard, Yiling Pharma builds innovative high-end technology incubation base, and provide multiple kinds of services for domestic and foreign enterprises, including contract sales service, contract manufacture for clinical sample and commercial production. Yiling Pharma will broaden management pattern, grasp market initiative, gradually build a global chemical drug research and development center and production and sales base, and constantly improve its own enterprise drug integrated innovation technology and international development capacity of API and formulations.
Yiling Group, as one of top pharmaceutical industry companies, is a high content of science and technology enterprises, since its inception has always been scientific and technological innovation as a driving point, the investment in scientific research increased year after year, 2016 ~ 2021 R&D investment amount of 240 million yuan, 260 million yuan, 360 million yuan, 520 million yuan, 740 million yuan, 838 million yuan. A number of breakthrough achievements have been made to solve one problem after another in the medical field. In future, Yiling Group will continue to make breakthroughs in the three major sectors of Traditional Chinese medicine, chemical &biological medicine and healthcare industry to benefit more people.