ScinoPharm Taiwan (stock code 1789) announced its consolidated revenue for 2020 of NTD 3.083 billion, after-tax net profit of NTD 282 million, and after-tax earnings per share of NTD 0.36. Faced with the highly uncertain global market last year and COVID-19, the company has maintained stable operations according to its original strategy. It has generated such revenue and profit that meet its expectations and continued to carry out business transformation and internal resources integration.
In terms of its API business development, the demand for API products has remained unabated; however, due to the impact of COVID-19 prevention policies and measures in various locations, there has been a delay by suppliers of main raw materials in performing their contracts to service certain manufacturing processes. This has hindered the production and sales of API products to a certain extent. Nevertheless, due to the completion of pre-production works such as material preparation a year ahead, coupled with the properly adapted production schedule as well as sales and transportation planning, the overall production activities and sales performance has been substantially unaffected. In the second half of last year, countries were actively involved in the research and development of vaccines and products that may become therapeutic drugs. ScinoPharm Taiwan also re-adjusted its delivery schedule in response to the needs of certain customers. CDMO has benefited from flexible sales strategies, periodic stocking requirements, and the customers’ great ambitions in developing products to address new indications, becoming a highlight of last year’s business performance.
In addition, the company’s first in-house-developed and manufactured injectable generic peptide formulation has been submitted to the US Food and Drug Administration (FDA) for review and approval. The strategy of extending the life cycle of existing products through vertical integration is in gradual implementation. Crossing over into complex injectable formulations is the first step of ScinoPharm Taiwan’s business expansion. In the future, it will continue to invest in the R&D and production of injectable formulations and establish strategic alliances that will add to and thus multiply its chances of seizing a greater share of the injectable formulation market; and it is also optimistic about the potential of the oral administration market, seeking to open up a brand new space in the highly competitive pharmaceutical industry.
The Changshu site underwent its first-ever on-site inspection of drug registration in 2020 that was conducted by the China National Medical Products Administration (NMPA) for food and drug registration, as well as the China GMP compliance inspection. It is expected to be approved for marketing in China this year, signifying real official entry into the China market for domestic sales. This product is an emergency medicine for rare diseases, against which there is no alternative treatment at present, and it is expected to become one of the main sales drivers of the Changshu site in the future. In addition to passing the GMP inspection by the U.S. Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), the Changshu site has other products under its partnership with Chinese customers that will undergo the intensive inspection procedures of competent authorities. This year, apart from finishing the inspection of another anti-cancer product that was developed in cooperation with a customer in February, there are two other products developed in cooperation with customers that will be submitted to the China National Bureau of Inspection’s Center for Food and Drug Inspection of NMPA (CFDI) for dynamic verification. The Changshu site is also focused on operational strategies and the integrated use of internal resources. It plans to have more flexible production line scheduling and use in compliance with the requirements of laws and regulations, and have closer cooperation with its customers.
About ScinoPharm Taiwan
ScinoPharm Taiwan is engaged in the production and development of APIs and injectable formulations required for the contracted research and development of generic drugs and new drugs. It provides customers with one-stop shopping services using its vertically integrated structure from APIs to injectable formulations. It has customers worldwide, including many of the world’s top ten manufacturers of patented drug manufacturers and major generic drug manufacturers. At present, the API products that have been developed and produced include anti-cancer, central nervous system, hormone, and anti-viral medications. It has also completed the drug master file registration in the major markets around the world and has developed 74 generic APIs, of which 32 have been approved. There are 869 valid Drug Master Files (DMFs) registered globally, including 63 in the United States. For more information, please visit the company’s website at http://www.scinopharm.com.