The vision of PharmaEssentia is to become a world-class innovative biopharmaceutical company. We aim to build a fully integrated company with our base of operations in Taiwan and with leading capabilities from R&D, pre-clinical tests and clinical trials, manufacturing, to the marketing in global markets after the drug permit licenses are obtained. This truly shows that our R&D and manufacturing are not only in line with Taiwan’s requirements, but that we are also able to extend our clinical trials and sales to European and American markets and be in line with their requirements. Through the cross-border R&D clinical cooperation model, we can not only learn from successful experiences, but we also can cultivate local talents in the field of biotechnology and biopharmaceutical industry.
PharmaEssentia was founded in October 2003 and became a TPEx-listed company in July 2016 with the stock code: 6446. PharmaEssentia is based in Taiwan with independent manufacturing and production capabilities, cultivating local talents in the field of biotechnology and biopharmaceutical industry, and actively developing strategic alliance partners to expand to the global markets. Our vision is to become a world-class innovative biopharmaceutical company and the bellwether in the field of Myeloproliferative neoplasms (MPN). We are looking forward to, start from Taiwan, establishing Taiwan’s first fully integrated protein innovative biopharmaceutical company that combines new drug R&D, clinical trials, manufacturing, marketing and sales.
In order to expand into markets around the world, PharmaEssentia has formulated two major globalization strategies: establishing foreign subsidiaries and partnering in-licensing, out-licensing and development to improve the efficiency of drug R&D and business development. In addition, in order to enhance the Company's global competitive advantage and create long-term value for the Company, the Company recruits local talents for clinical trials, marketing and sales which can shorten inter-national discrepancies, reduce investment costs and accumulate international experiences.
The Company was founded as an innovative drug R&D company for protein biopharmaceuticals, with the PEGylation technology platform as its biggest competitive advantage. Applying the Company’s proprietary PEGylation technology platform to different indications can not only shorten the development timeline of new products, reduce the risk of new product development and research funding, but also create advantageous product portfolio for future business expansion, and can reduce possible competition risks that a single product may cause. In addition to our successfully developed new generation long-acting interferon, Ropeginterferon alfa-2b (P1101), the Company also conducts various exploratory researches.
Since the establishment of the Company, it has been known for its outstanding R&D capabilities. Therefore, applying patents in various counties around the world for our R&D results is the most important value reflecting our operation. The Company coordinates with R&D progress of each project and applies at the right time, in the right country, for different types of invention patents to carry out the global technology deployment. As of the end of 2019, the valid patent rights have been certified in many countries across the world, and the cumulative number of valid certifications has reached 75. Regarding our trademarks, the total number of registered trademarks obtained in various countries in 2019 has reached 55. As early as in 2018, when the Company was about to obtain the marketing authorization in many countries for the百斯瑞明® / Besremi® ahead of schedule, it applied for registration or registration transfer of more than 60 trademarks to expand its intellectual property rights to a global scale.
The company follows the Policies of Regulation for internal controls and R&D cycles which established on June 20, 2017 to standardize the Procedures for the Management and Application of Intellectual Property Rights where the management of the Company’s intellectual property rights embodies the three major aspects of acquisition, management and utilization. The company’s intellectual property department reported to the BOD about the company's intellectual property management system and the implementation of intellectual property rights of the group at the 5th Board meeting on August 11, 2020, and all directors have been informed and agreed.
PharmaEssentia complies with the Declaration of Helsinki, the GCP guidelines from the International Council of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP), and our clinical trial plan has received approval for investigational new drug (IND) application and phase I, II, and III clinical trials as required by laws and regulations of the local government. PharmaEssentia expects to complete more than 19 standard operating procedures of clinical trials and 5 standard operating procedures related to medical affairs by the end of 2020.
The Company completed the construction of the Taichung biopharmaceutical manufacturing plant in 2012 and obtained the GMP certification in 2013, laying a solid foundation for the R&D and manufacturing potentials of biopharmaceutical factories. In 2018, it became the first protein biopharmaceutical plant in Taiwan which passed the evaluation from EMA and obtained a GMP certification for our protein drug plant. In October 2019, the EMA conducted the first routine inspection on the Taichung plant and the Taipei plant after the start of commercial mass production. The two plants had no critical findings and no major deficiencies and successfully passed the routine inspection of the EMA at one time. The newly established filling plant also obtained approval from the TFDA evaluation and the GMP and Good Distribution Practice (GDP) in April 2020, completing the last piece of the puzzle of all the licenses required for the production of Ropeginterferon alfa-2b (P1101). The Company has currently established a complete and vertically integrated supply chain. It is now an international biopharmaceutical company with leading capabilities. From full production, quality control, filling, and shipment, it can expand to the global markets.
Thanks to our Company’s years of R&D and clinical trials efforts, the Ropeginterferon alfa-2b (P1101) was officially marketed in Europe in 2019 under the trade name Besremi®. Sales started in the EU market through the assistance from our strategic partner AOP Orphan, currently 11 countries have approved sales in their markets. In 2019, Besremi® generated sales revenue of NT$ 290 million for the Company. For the Taiwanese market, we have obtained a marketing license from the TFDA in May 2020, and the Company has acquired a marketing team, and is expecting to launch the sales under the brand name 百斯瑞明® in Q1 of 2021.
|2019 CSR Report|