For enterprises, innovation is always the core proposition. For pharmaceutical companies, innovation is the foundation of survival, and they are responsible for exploring the issues of human life.
Recently, Shandong Xinhua Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinhua Pharmaceutical") dobutamine hydrochloride injection and rabeprazole sodium enteric-coated tablets have successively passed the consistency evaluation of generic drugs, and valsartan amlodipine tablets (I) have obtained the drug registration certificate, demonstrating the company's strong R&D level and quality control capabilities.
At the 2023 Misi Conference (China Pharmaceutical and Health Industry Symbiosis Conference) held not long ago, Xinhua Pharmaceutical was selected into the "2022 Top 100 Chinese Chemical Pharmaceutical Enterprises List", and the new products Bulin (ibuprofen suspension) and Nolantai (Sevellamer carbonate tablets) also made a stunning appearance.
From APIs to high-end preparations, from generic drugs to original drugs, Xinhua Pharmaceutical, an "80-year-old" veteran pharmaceutical company, has laid a solid foundation, continued to advance, continued to release its innovation potential, practiced the original mission of "protecting health and benefiting society", and led the high-quality development of Shandong's biomedical industry.
01 Increase investment and continue to innovate
Many people's understanding of Xinhua Pharmaceutical is still stuck in the old API company. More people know Xinhua Pharmaceutical because of the company's star product ibuprofen.
In fact, although it started with antipyretic and analgesic drugs, and is still an important global production and export base of antipyretic and analgesics, Xinhua Pharmaceutical has already made a gorgeous transformation with its strong R&D and innovation capabilities, breaking through the "old impression" in people's traditional cognition.
The innovation and development of pharmaceutical enterprises is a long-term project, which not only tests the scientific overall planning of managers, but also cannot be separated from a large amount of investment in the field of research and development. Let's start with a set of data:
In 2020, Xinhua Pharmaceutical's R&D expenses were RMB29.8 billion yuan, an increase of 26 over the same period last year74%；R&D expenses in 2021 were 34.1 billion yuan, an increase of 14 over the same period last year42%；R&D expenses in 2022 are 34.6 billion yuan, an increase of 1 over the same period last year26%, ranking fourth in the R&D investment of biomedical A-share listed enterprises in Shandong Province.
It can be seen that since entering the "14th Five-Year Plan", Xinhua Pharmaceutical's R&D expenses have continued to increase significantly. During the "13th Five-Year Plan" period, Xinhua Pharmaceutical's R&D expenses have also been invested by a total of 9600 million yuan, with an average annual growth rate of 294%。
From the original API-based, to generic drug preparations, to the production of innovative drugs, and into the big health products, Xinhua Pharmaceutical is constantly expanding the field of research and development, extending the industrial chain forward and backward, optimizing and adjusting the industrial structure, and innovative achievements are constantly emerging.
After years of development, Xinhua Pharmaceutical has formed a complete industrial chain from pharmaceutical intermediates, high-quality APIs, high-end preparations to the commercial sector, and in 2022, Xinhua Pharmaceutical's operating income will be composed of: chemical drug preparation manufacturing industry accounts for 4256%, and the chemical drug manufacturing industry accounted for 4227%, pharmaceutical intermediates and others accounted for 1516%, the product structure is optimized and improved.
According to public information, Xinhua Pharmaceutical currently has 8 exclusive domestic varieties such as ethoxybenzalamide, triphenylbiamidine, and marin, and each product chain includes more than a dozen products, including pharmaceutical intermediates, APIs, and preparation production.
According to the 2022 annual report, during the reporting period, Xinhua Pharmaceutical obtained 7 approvals for new products such as irbesartan hydrochlorothiazide tablets, 5 approvals for consistency evaluation such as Dunling, 4 approvals for APIs such as sevelamer carbonate, and 56 new products under development.
02 New products are constantly being developed and developed
The early investment is now reaping the rewards. Since the beginning of this year, Xinhua Pharmaceutical's new drug field has been full of good news.
As China's largest integrated manufacturer of ibuprofen APIs and tablets, Xinhua Pharmaceutical's self-developed ibuprofen suspension was recently approved for marketing, which further enriched the company's ibuprofen series products and provided convenience for pediatric patients.
In addition, the company's generic drugs dobutamine hydrochloride injection, rabeprazole sodium enteric-coated tablets, sevelame carbonate tablets, etc. have also passed the consistency evaluation.
Among them, multi-department emergency large variety dobutamine hydrochloride injection is mainly used for heart failure, and Xinhua Pharmaceutical is the second enterprise in China to pass the consistency evaluation of this varietyRabeprazole sodium enteric-coated tablets are the third-generation proton pump inhibitors, and Xinhua Pharmaceutical uses self-produced raw materials, which is the third enterprise in China to pass the evaluation of this productSevelamer carbonate tablets, a Class B variety of national medical insurance, are used to control hyperphosphatemia in patients with chronic kidney disease (CKD)** undergoing dialysis**, and before that, the sevelamer carbonate API developed by Xinhua Pharmaceutical has also been approved for marketing.
Xinhua Pharmaceutical's valsartan amlodipine tablets (I) preparation also obtained the registration certificate in May, and the product is mainly for essential hypertension, which is a Class B variety in the medical insurance catalog, enriching the company's cardiovascular and cerebrovascular drug product line.
In terms of chemical raw materials, alogliptin benzoate and acetamide, the exclusive chemical raw material of Xinhua Pharmaceutical, have also been approved. In terms of health food, Xinhua Pharmaceutical has broken through the foreign technology monopoly on high-end fish oil separation and purification, and successfully realized the self-production of high-purity fish oil raw materials.
It is understood that in the first quarter of this year alone, Xinhua Pharmaceutical has obtained 6 new product approvals and 2 clinical approvals for innovative drugs, a record high. The R&D of Xinhua Pharmaceutical is still continuing.
In terms of original drugs, Xinhua Pharmaceutical has entered the field of popular Alzheimer's disease (AD) drugs, and OAB-14, jointly developed by the company and Shenyang Pharmaceutical University, is in the clinical stage.
Although AD drugs have broad prospects, they are also recognized as difficult to develop in the world. For any pharmaceutical company, without enough courage, resilience and strength, investing in AD drug research and development will be a huge challenge, including Pfizer, Roche, etc., many well-known pharmaceutical companies have suffered setbacks in this track.
But Xinhua Pharmaceutical is willing to collapse its body to overcome difficulties and gnaw this "hard bone". This is not only the original intention of Xinhua Pharmaceutical's mission of "protecting health and benefiting society", but also the responsibility and responsibility of state-owned enterprises, and the specific practice of Xinhua Pharmaceutical's "innovation-driven and high-quality development".
03 Prioritize efficiency and empower digitally
In Xinhua Pharmaceutical, innovation and breakthrough have become the spiritual core of the enterprise, which is not only reflected in drug research and development, but also in all aspects of enterprise development.
Whether it was the first to establish a quality control system for the whole process from raw materials entering the factory, production links to product delivery in 1986, or the first tablet production workshop in China that met GMP standards was built and put into operation in 1992, or the shareholding system reform began in 1993 and was issued and listed on H shares and A shares in 1996, reviewing the development history of Xinhua Pharmaceutical is a history of development and innovation of the pharmaceutical industry in New China.
In the new era, digital transformation has become an inevitable trend to improve the operational efficiency and core competitiveness of enterprises.
In the digital workshop of high-end solid preparations of Xinhua Pharmaceutical, various international leading intelligent equipment is integrated, and advanced technologies such as big data, artificial intelligence, and Internet of Things + are used to realize the digital management of the whole process of production process, quality control, equipment management, warehousing and logistics, and drug life cycle.
In May this year, the workshop won the third prize of the first state-owned enterprise digital scene innovation professional competition held by the State-owned Assets Supervision and Administration Commission. Prior to this, the workshop has passed the on-site audit of the US FDA, the UK MHRA and the domestic GMP, and has been rated as a digital workshop in Shandong Province, the first batch of "Modern Advantageous Industrial Clusters + Artificial Intelligence" projects in Shandong Province, and a pilot demonstration project for the digital transformation of Shandong provincial enterprises.
Xinhua Pharmaceutical continues to promote the development of the industrial Internet, and has built and upgraded the first phase of the solid preparation cooperation center, the automated three-dimensional warehouse, the second phase of the solid preparation cooperation center, and the injection GMP transformation project. The company was selected as the first to be selected into the list of provincial smart factories in 2022 and the list of intelligent manufacturing benchmarking enterprises in Shandong Province in 2022.
In terms of optimizing the management mechanism, Xinhua Pharmaceutical has built an integrated business collaboration platform for enterprises, supervised the whole process of "orders, flows, markets, expenses, and commissions", quickly realized business response to business tracking and processing, met the collaboration of all salesmen of the enterprise, and realized efficient mobile office. At the same time, Xinhua Pharmaceutical has built three cloud platforms, including a cloud platform for quality audit, a cloud platform for industrialization guidance, and a cloud platform for equipment operation and maintenance, and uses industrial AR to achieve efficient business management.
To accelerate digital and intelligent transformation, Xinhua Pharmaceutical's traditional business processes have been deeply integrated with digital technology, achieving new breakthroughs in production, management and operational efficiency, and continuously improving its innovation capabilities, becoming a benchmark enterprise for manufacturing enterprises to improve quality and upgrade.
Text: Xiaoyang).