01

Chairman Ching-Leou Teng: Continuous Improvement and A Wholehearted Commitment to Sustainability

2021 is a year of challenges and breakthroughs. Though the world was severely affected by the COVID pandemic, it was also swept by a wave for sustainability. PharmaEssentia was able to re-evaluate and gradually fortify our road map to sustainability amidst such trends. At the end of 2021, Ropeginterferon alfa-2b (P1101), the next-gen long-acting interferon used to treat Polycythemia Vera (PV), was authorized by the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety (MFDS), and medicament license was obtained from both the U.S. and South Korea under the product name BESREMi®. Moreover, exclusive distribution agreement for seven years in the United States' Market is obtained for its orphan drug status. Not only does this represent the greatest recognition and encouragement for PharmaEssentia’s global team, but it also realizes our mission of “Better science, Better lives,” in which we strive to alleviate the pain and bring a better life for all of mankind through scientific R&D of new drugs.

With such breakthrough comes even more social responsibility. This is the third year for PharmaEssentia’s sustainable development, and over the past two years, we strove to build a sustainable development road map and to realize our goals. Our efforts were rewarded with a Gold Medal in Sustainability Report in the medical insurance sector from the 14th Taiwan Corporate Sustainability Awards in 2021. In terms of risk control, the ESG risk evaluation from international third-party agency Sustainlytics was also reduced from High Risk to Moderate Risk; furthermore, we were also invited to complete the S&P Global Corporate Sustainability Assessment (CSA) from Dow Jones Sustainability Index (DJSI) and ranked at 92 percentiles of all pharmaceutical companies in the world for the first time. It shows our efforts are positively received by international sustainability agencies. We relaunched material topic identification in this 3rd sustainability report to be published this year. We will explore PharmaEssentia’s sustainable topics with a more comprehensive perspective and invite more stakeholders throughout the world to engage in our path toward sustainability. Data from foreign subsidiary in the United States is also included to practice the 3 major aspects of environmental, social, and governance (ESG) and to continuously enhance our long-term sustainable value.

Since founded in 2003, PharmaEssentia has always taken a patient-oriented approach, standing at the forefront of medical technology to seek innovative biological drugs and providing high-quality medicines with accurate, transparent and effective drug information to support the healthy lives of people around the world. To date, BESREMi® has successfully obtained medicament license from over 30 countries, including the European Union, Liechtenstein, Israel, Taiwan, South Korea, and the United States, and it is used by patients around the world. We are gradually addressing our commitment to “cater to unmet medical needs around the world, to explore and develop potential new medicines and technologies, and to provide affordable and accessible medicines to patients”. Looking ahead, under our strategy of globalization and continuous development of innovative new drugs, we will continue to recruit talents in biopharmaceutical R&D and various professional fields to develop high-quality new drugs with the best technology and the highest quality control, while achieving optimized business strategies and fulfill our sustainable commitment to drug accessibility to satisfy the expectations and needs of all stakeholders.

Finally, we also cordially invite you to read this sustainability report and welcome your valued advice and suggestions. We will carry on to work tirelessly for continuous improvements and innovations on this path toward sustainability, and to become a reliable and accountable biopharmaceutical company to all stakeholders. Thank you!

02

CEO Ko-Chung Lin: Develop Locally and Expand Globally while Upholding Our Mission

In spite of the various challenges and impacts, including the COVID-19 pandemic, climate change, and global geopolitical frictions in recent years, everyone throughout PharmaEssentia’s global operations continued to work together to achieve medicament licenses for the next-generation, long-acting interferon, Ropeginterferon alfa-2b (P1101), throughout the world. The drug has obtained the EU medicament license for treatment of Polycythemia Vera (PV) under the product name BESREMi® as well as medicament license from the Taiwan Food and Drug Administration (TFDA) since 2019, and was further granted medicament license by Israel, South Korea, and the United States in 2021, benefiting PV patients throughout the world. To date, our Taichung Plant is certified with the Good Manufacturing Practice for Medicinal Products (GMP) from TFDA, GMP from the EU’s European Medicines Agency (EMA), GMP from South Korea’s MFDS, and further passed the U.S. FDA’s GMP plant verifications in 2021. To achieve our sustainable vision for drug accessibility through our core competencies, we have prepared the expected drug demand for the upcoming year in the U.S. market and aim to increase patient usage after product launch via stable and safe supply chain and well-rounded “SOURCE patient care program”.

In addition to the treatment of PV, we will continue to expand the clinical application of Ropeginterferon alfa-2b (P1101) to draw on the strengths of creating "one drug for multiple indications." The phase III clinical trial of Ropeginterferon alfa-2b (P1101) for Essential Thrombocythemia (ET) had initiated in Taiwan, Japan, South Korea, China, the United States, Canada, and Singapore. We are actively recruiting trial subjects and expect to file for drug licence for ET treatment after the phase III trial. To contribute toward epidemic preventions in Taiwan, when Taiwan was heavily impacted by the pandemic, we actively launched the “PharmaEssentia Can Help” project to actively provide BESREMi® to medical institutions that participated in the clinical trial to treat mild to moderate COVID-19 patients.

As the world enters a post-pandemic era, PharmaEssentia’s years of precious experience since it was founded have prompted us to face various challenges with a more positive and proactive outlook. This is the gene for resilience and sustainable operations found in all PharmaEssentia employees. As a comprehensively integrated biopharmaceutical company founded in Taiwan and engages in new drug innovations and R&D, trial development, manufacturing and production, and drug marketing and sales worldwide, our goal is to become an international pioneer in the area of biopharmaceutical development. This is a challenging path and we aspire to lead Taiwan’s biotech and pharmaceutical industry to grow and shine in the international market, and to become a beacon of hope for patients worldwide.