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
Key Strategies and Actions on Access to Medicine
Globalizing Local Capacity Building and Access to Healthcare
Management Approach on Access to Healthcare
PharmaEssentia adheres to a patient-centered approach, and plans various actions and support programs to implement access to medicine and meet patients' health-related needs. Through activities such as health education, financial and medical support, academic exchanges and more, we provide patients with a comprehensive and integrated plan that covers every stage of their treatment. For patients already using BESREMi, a series of health promotion activities have been planned to extend their medication duration and improve overall treatment outcomes. By promoting local Healthcare and social participation to expand our external social influence.
Value Chain Empowerment Program
Intellectual Property Sharing Promotes Access to Medicine
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.
Intellectual Property Right Commitment
Patent and Trademark Management Policies and Performance
Technology Licensing can Maximize the Value of Intellectual Property
Short-to-Medium-Term Drug License Registration Plan
Global Marketing and Market Promotion
Tackling Medical Costs
Improving Product Medical Efficiency
Improving medical efficiency by providing innovative drugs that contribute to healthcare is a goal that PharmaEssentia strives to achieve. We have completed a comprehensive economic evaluation, including cost-effectiveness, cost-utility, and cost-benefit analysis, for BESREMi® upon its launch in Europe, to analyze the product's impact on medical costs. BESREMi® has achieved a coverage rate of 100% and has already been included in the ELN guidelines in 2021. As for the US market, BESREMi® is the first interferon approved by the US FDA for the treatment of PV, a rare blood disorder, and is eligible for orphan drug licenses. It has also been included in the NCCN guidelines for PV treatment. BESREMi® can be used as a suggested treatment for PV in adults, regardless of previous treatment or high-risk population status. The guidelines also include details on recommendations, providing comprehensive advice for medical practitioners on diagnosis, treatment, and patient management. We are actively collecting relevant data as the basis for future medical technology evaluations to certify the medical value of BESREMi®.
Fair and Reasonable Pricing
When pricing our drugs, patient interests are our top priority. We take into consideration various factors, such as the investment in research and development, the number of patients who would benefit from the treatment during the patent period, the pricing of competing products, expected profits, third-party insurance claims, and health insurance coverage provided by regulatory authorities. We then use these factors to determine a fair price, taking into account the ability of different countries to afford the medication, their level of economic development, and the cost of manufacturing the drug. We also refer to the WHO Guideline on Country Pharmaceutical Pricing Policiespublished by the World Health Organization to determine reasonable and fair drug prices.
Contributions Throughout a Patient's Treatment
PharmaEssentia not only stops at the development of new drugs but takes concrete action to improve patient care throughout their treatment.。
Ethical Pharmaceutical Marketing
Our company strictly adheres to all applicable industry regulations and stipulated provisions in marketing and sales, ensuring that all relevant personnel receive appropriate training and comply with ethical standards. In 2022, there were no violations of any marketing and communications-related regulations, and the company adhered to ethical pharmaceutical marketing practices.
Ethical Policies and Commitments for Drug Marketing
Annual implementation of Corporate Sustainable Development
【Annual implementation of Corporate Sustainable Development _2022】
1. Respond to the new green energy conservation and innovation public welfare, and sponsor Jane Goodall Institute to
replace two sets of hydrocarbon refrigerants in air conditioning system and reduce carbon emissions. The public
welfare project is in line with the goals of SDG13 and SDG 4 of the United Nations.
2. PharmaEssentia supported Digital Humanitarian Association to implement the Healthy Aging In Place, contributed to
Rural Health Promotion Philanthropy. The philanthropy project is in line with the goals of SDG3, SDG8 and SDG10 of
the United Nations.
3. In order to implement the Taiwan Patient Healthcare Education and Medical Contribution , in September 2022, we
assisted the Taiwan Myeloproliferative Neoplasms Association (TMPNA) to hold a press conference to serve and care
for patients with myeloproliferative tumors and their families.
4. The subsidiary, Panco, assisted TMPNA and CHIA-YI MPN Center to jointly hold the first national healthcare education
lecture for patients in October 2022.
5. The subsidiary , Panco, set up the interactive platform "MPN iCare " to provide healthcare education to patients and
their families. To promote the physicians' new knowledge of the MPN field and the effectiveness of long-acting
interferon treatment, 4 healthcare education activities were held in 2022, with a total of 28+person of manpower
input, and a total of nearly 800 people participated.
6. Commenced patient health care program “SOURCE” in line with medical personnel to serve patients in the US.
7. The NCCN Guidelines has included Besremi (Ropeginterferon alfa-2b) as a recommended therapeutic option for
Adults with Polycythemia Vera (PV).
8. 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 2022.
9. In April 2022, the CEO was invited to the Demo Day of a professional platform for the bio-ecosystem energy and
capability of the National Biotechnology Research Park to give a keynote speech on "Global Trends in the
international biotechnology and pharmaceutical Industry ". To share the R&D achievements, increase
cooperation opportunities, and accelerate industrial development to activate Taiwan's biotechnology ecosystem.
10. In April 2022, the factory director was invited to the 2022 Taiwan Biotechnology and New Drug Industry Analyst
Cultivation Credit Class of the National Yang Ming Chiao Tung University Continuing Education Center. To share the
course of "Analysis and case study of biological drug product development strategy" to cultivate students to become
professionals in the field of biological medicine and promote the fund-raising and development of biological
technology and new drug industry.
11. In May 2022, co-sponsored with TRPMA & CDE Academy, hosted the "Regulatory Considerations and Experience of
Taiwan's New Drug Research and Development Quoting Overseas Data". The chairman and team of PharmaEssentia
will share the experience, strategy and skills of submitting for the US BLA with overseas data from the aspects of CMC
and clinical trials, and assist Taiwan's new drug companies to understand the regulatory strategy of using overseas
data for the listing of new drugs.
12. In August 2022, the factory director was invited to the physical and online seminar of the Taiwan Light and Salt
Biotech Institute to share new drug development strategies_ New drug development topic selection and process
sharing, international layout strategy_Sharing of drug certificate application process, from LAB to GMP
manufacturing_Valuable experience in technology transfer operation and process validation, official factory
inspection preparation, etc.
13. From 2019 to 2022,Pharmaessentia has been sponsoring One Song’s New Year Concert, for 4 consecutive years.
Attended by 32 individuals in 2022.
Contribution to Access to Medicine
Our original intention is to continue to pursue the core competence of innovative science, combined with our Access to Medicines Strategy Program. By promoting local Healthcare and social participation, and linking Value Chain Empowerment Program to expand our external social influence. We also focus on Tackling Medical Costs so as to reduce access disparities and enhance patient health and well-being.