Our original intention is to continue to pursue the core competence of innovative science, combined with our Access to Medicines Strategy Program, so as to conduct the development of new drugs and will continue to promote “Accessibility”to new medicines for patients around the world, and meet the supply through legal and safe channels. Besides, set fair, reasonable and affordable prices to make patients “Affordability”, assist patients in economically disadvantaged countries to “Availability” new drugs, and reduce access disparities. We maximize patient coverage in global markets as much as possible to enhance patient health and well-being.
Governance on Access to Medicine
Management Approach on Access to Medicine
Access to Medicine Strategies and Performances
Innovative medicine - solving unmet medical needs
We have successfully developed a new generation of PEG-based long-acting alpha interferon drugs based on our PEGylation Technology Platform to improve on existing drugs, reduce the risk of new drug development, with the characteristics of one drug for multiple indications, so as to achieve the value of innovating and creating access to medicine. At present, our Company has simultaneously promoted more than 20 clinical trials, benefiting more than 1,500 patients in total. We also served as the Compassionate Use drug for the treatment of MPN. The total number of approved cases before the launch in Taiwan was 39 cases and the first compassionate use in Korean patient, a total of 40 by 2021.
Improvement of Existing Drugs to Reduce the Risks of New Drug Development
Effectively Develop Diverse Products Through Technical Platform
Using Ropeginterferon alfa-2b (P1101) in Compassionate Use to Benefit the Patients
Sharing of intellectual property rights
PharmaEssentia attaches great importance to the transparency and sharing of intellectual property rights and take patent rights as the layout of business development strategy. we licensing-out patents and technologies from large foreign pharmaceutical strategic partners, licensing- in to introduce potential patents and technologies .We will establish a systematic management mechanism for licensing-out and licensing-in management based on our own patents and technologies, in order to maximize the management efficiency and social value of intellectual property rights. In the future, the Company promises to take into consideration the access to medicine of patients in least developed countries (LDCs) and low income countries (LICs) when utilizing and applying for patents to ensure the treatment needs of patients.
Stable and Safe High-Quality Drugs
To ensure that patients can obtain safe and high-quality drugs on a timely basis, we inspect and consider all factors that may affect patients’ accessibility to drugs in all management actions related to the right to the access of medicine, and draft solutions accordingly. By enforcing quality management before, during, and post- production and post-marketing, we provide a safe, stable, and timely delivery of drugs to patients so that the patients’ needs can be met.
Patient Relation and Community Engagement
Management Approaches for Patient Relation and Community Engagement
Patients are the most important stakeholders to Pharmaessentia. We uphold the concept of patient-centered and provide an integrated package of both medical support and healthcare education to the patients, we aim to enhance patient education, promote research on relevant diseases and to raise the public’s awareness by organizing healthcare education, medical and academic seminars and activities related to BESREMi®/百斯瑞明® around the world.This would help to reduce the patients’ out-of-pocket medical expenses and barriers to medical access, and we also flexibly and rapidly match the patients’ medical needs with various medical and healthcare assistance organizations, thereby allowing appropriate patients to receive the medicines they need and to actively begin relevant treatments. In Taiwan, we collaborated with Chiayi Chang Gung Memorial Hospital to establish Taiwan’s first MPN center to execute action plans related to patient health, such as:
- Help all patients who use drugs from PEC to clearly understand the characteristics of diseases, mechanism of drug action, and medication.
- Promote knowledge related to the diseases and provide treatment consultation and referral service.
- Care for patients’ health and continue to follow-up during the treatment process.
- Promote local medical and healthcare and social engagement to expand Pharmaessentia’s external social influence.
Sponsor to hold MPN Asia
Sponsored the MPN Asia for 5 consecutive years, invited European/American experts and scholars to share clinical experiences to promote interactions and sharing of the latest treatment perspectives between Asian experts, scholars, and clinical physicians.
Short- and mid-term drug license application plans to expand global market penetration
We have successfully developed the product Ropeginterferon alfa-2b (P1101) for the treatment of rare blood disorders and have successfully obtained regulatory marketing approval for the treatment of PV in over 30 countries including the European Union, Switzerland, Liechtenstein, Israel, Taiwan, South Korea, and the United States. We continue to apply for PV regulatory marketing approval applications for PV to competent authorities of other countries, and to realize the equal right to medical equality for the patients worldwide step by step. Subsequently, we are planning to apply for the regulatory marketing approval for the treatment of a rare hematologic disease, essential thrombocythemia (ET). We hope to bring the drug into all corners of the world for the treatment of patients with rare diseases, bringing new hope to their lives.
Proving the Economic Values of Products Through Fair & Reasonable Pricing
The patients’ rights are the first and foremost concern in setting the prices for Pharmaessentia’s drugs. We believe that we can only care for all patients in need through setting fair, reasonable and affordable prices. When setting drug prices, we take into consideration the overall factors covering the R&D costs invested, as well as reimbursement landscape in various countries. We formulate reasonable and fair prices based on the affordability of medical expenses, economic development, and drug preparation costs in various countries, also with reference to the “WHO Guideline on Country Pharmaceutical Pricing Policies” announced by the WHO.
Patient Healthcare Education and Medical Contributions
After obtaining approval for Ropeginterferon alfa-2b (P1101) used to treat polycythemia vera (PV), we have actively begun our "patient healthcare support program" in various countries and regions. Through interaction with patient organizations to understand patients’ needs and to support related research and development.
Patient Safety Management
We comply with GVP standards, and the headquarter has also established a pharmacovigilance function team responsible for integration of drug safety information in various countries. A Real-Time Reporting System, Product Serialization Management System and Product Recall Management System have been established to effectively and quickly recall drugs through a perfect product traceability mechanism when drugs have safety concerns, so as to ensure the safety of patients. There were no drug recalls have occurred during 2021.
Annual implementation of Corporate Sustainable Development
- Since the first seminar in 2016 to 2021, Pharmaessentia has been sponsoring MPN Asia for five consecutive years. The conference brings together experts and clinicians from many countries for in-depth interaction and academic exchange on the research and treatment of blood diseases.
- Collaborated with Chiayi Chang Gung Memorial Hospital to establish Taiwan’s first MPN center to reinforce Taiwan’s medical research in terms of myeloproliferative neoplasm (MPN) and to be more aligned with international trends.
- PharmaEssentia and Panco Healthcare assisted in organizing 2021 Taiwan MPN Workshop, which was attended by 167 individuals.
- To contribute toward epidemic preventions in Taiwan, we 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 cases.
- Commenced patient health care program “SOURCE” in line with medical personnel to serve patients in the United States
- Sponsored two health promotional events, “2021 Joining Young Patients” and “Relaunching Health” for hemophilia patients, and assisted patients at Tung’s Taichung MetroHarbor Hospital and Sin-Lau Hospital to learn the latest health care and medical information.
- Panco Healthcare organized MPN Nurse Seminar, which was participated by 30 medical staff from 14 hospitals.
- From 2020 to 2021 , Pharmaessentia has been sponsoring One Song’s New Year Concert, for 3 consecutive years. Support the development of culture & art and bring vitality to the social economy. It can cultivate employees' personal body & mind, combine work & rest, balance life & workplace relations, and promote a new ecology of integration and mutual benefit. Attended by 52 individuals in 2022.
- We participated in 3 sessions of industry-academia exchanges in 2021, including the “MPNs and R&D of New Drugs Practices” in May at National Central University; PEC was invited to shared our experiences in “CMC & Clinical in successfully launching a biopharmaceutical drug” at Nangang Biotech Incubation Center by the Biopharmaceutical Committee of the Taiwan Pharmaceutical Manufacturer’s Association in October, and conducted a speech on “A Fully Integrated Operating Global Biopharmaceutical Company in Taiwan” at Bio-Asia in November. We also co-organized investors conference and recruitment fair with Academia Sinica and businesses from the Nangang Biotech Incubation Center to contribute toward the biotechnology industry in Taiwan as well as to increase our external social influence.
- We served as the Compassionate Use drug for the treatment of MPN. The total number of approved cases before the launch in Taiwan was 39 cases and the first compassionate use in Korean patient, a total of 40 by 2021.
The Chapter of Access to healthcare and medicine pricing
Our original intention is to continue to pursue the core competence of innovative science, combined with our Access to Medicines Strategy Program. We conduct to promote the “Accessibility”, “Affordability”, and “Availability” of new medicines for patients around the world, so as to reduce access disparities and enhance patient health and well-being.