Company Overview

Company Description

OUR MISSION

We endeavor to create value by supplying unique, first-class innovative drugs, which are effective and safe for our customers’ health. We pursue to be a valuable business organization held in high esteem by the people.

We are a science-driven biotechnology company based in Taiwan and are committed to developing and commercializing innovative and differentiated new drugs (plant-derived) mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia (primarily Taiwan and mainland China).

Since our inception in 2002, we have been dedicated to the research and development of new drugs with high safety and efficacy. Through 20 years of efforts, we have built integrated capabilities that encompass all key functionalities of drug development, including early-stage drug discovery and development, clinical trials, regulatory affairs, manufacturing and commercialization. Leveraging our strong research and development capabilities and proprietary platform, we have been developing a series of drug candidates, including one core drug candidate at NDA stage, one clinical-stage key drug candidate and other preclinical-stage drug candidates. Among our drug candidates, we have filed the new drug application, or NDA, for MCS-2 in the U.S. One of our clinical-stage key drug candidates, PCP, is under phase II trials stage in Taiwan. Another preclinical-stage key drug candidate, IC, is under preclinical studies.

Our pipeline features three innovative and differentiated new drug candidates, and we are developing them for (i) the treatment of benign prostate hyperplasia/lower urinary tract symptoms, or BPH/LUTS, (ii) prostate cancer prevention, and (iii) the treatment of interstitial cystitis, respectively.

• MCS-2: MCS-2 is our new drug candidate developed for unmet medical needs of BPH/LUTS treatment. MCS-2 is expected to be our core product in the future. MCS-2 is a softgel containing patented active pharmaceutical ingredients of carotenoid chylomicrons. MCS-2 contains carotenoids, and we have further developed MCS-2 formulation using chylomicrons, a type of lipoprotein particles in human body, for the improvement of bioavailability. MCS-2 has a powerful antioxidant capacity and can reduce inflammatory cytokines. It takes effect by reducing oxidative stress and inflammation and has a dose-response effect. We have completed the four phase III clinical trials for MCS-2 in the U.S. and Taiwan, including two pivotal trials and two open-label extension study trials. The pooled study results of our phase III clinical trials on MCS-2 show that the primary endpoint (namely, the change in the total scores derived from the International Prostate Symptom Score system, or I-PSS, which is a validated, reproducible scoring system that measures severity of lower urinary tract symptoms and responses to therapeutics) has reached statistical significance and exhibited safety profile. We submitted a new drug application of MCS-2 using Active Pharmaceutical Ingredient-1, or API-1, to the U.S. FDA in December 2021 and received a filing confirmation letter from U.S. FDA on February 22, 2022. However, after reviewing our application materials, the U.S. FDA has suggested us to identify an additional resource for API-1, in case of a short supply of API-1. After a due research and development, we have identified Active Pharmaceutical Ingredient-2, or API-2, an ingredient that has the same composition of API-1, the patent of which is owned by us. We have submitted the comparative data of API-1 and API-2 for U.S. FDA’s review. Once the U.S. FDA requires us to conduct any specific additional study after finishing the review, we may submit the relevant study data to the U.S. FDA by the end of 2024. BPH/LUTS is the most common urinary tract disease in the middle-aged male population. According to Frost & Sullivan, the global prevalence of BPH increased from 88.4 million in 2017 to 94.2 million in 2020, representing an increase of 6.5%. The global BPH drugs market increased from US$3.7 billion in 2017 to US$4.1 billion in 2020, representing a CAGR of 4.6%. We are establishing a strong sales and marketing team that is expected to consist of employees with rich experience in relevant areas and our target markets, and plan to work with both domestic and international business partners to seize the great market opportunities and to help more patients reduce their distress caused by BPH/LUTS and drug side effects caused by chemical drugs.

• PCP: PCP is our key new drug candidate developed for the prevention of prostate cancer. Similar to MCS-2, PCP works through its mechanism of antioxidant and anti-inflammatory. PCP contains several types of patented active pharmaceutical ingredients of carotenoid chylomicrons that reduce oxidative stress and inflammatory cytokines (IL-6), both of which are main causes of many chronic inflammatory diseases. PCP and MCS-2 are essentially the same in terms of composition of active ingredients, dosage form, strength and route of administration; however, they are different drug candidates targeting different indications. We are conducting phase II clinical trials of PCP in Taiwan. Prostate cancer begins when cells in the prostate gland start to grow out of control. In general, the more quickly prostate cells grow and divide, the more chances there are for mutations to occur. According to Frost & Sullivan, the global prevalence of prostate cancer increased from 10.0 million in 2017 to 11.2 million in 2020, representing a CAGR of 3.9%. The global prostate cancer market increased from US$9.7 billion in 2017 to US$12.6 billion in 2019, representing a CAGR of 9.1%. In addition, the prostate-specific antigen abnormal population, or PSA abnormal population, representing men over 40 years old with a prostate-specific antigen test value of 4.0 ng/ml or higher, is exposed to a high risk of prostate cancer. From 2015 to 2020, the total number of PSA abnormal populations in the U.S., Taiwan and China increased from 5.0 million to 5.3 million.

• IC: IC is our additional key new drug candidate which is composed of polysorbate loaded micelles as nanocarriers which can be used in the intravenous injection and intravesical instillation. The micelles enhance the bioavailability by prolonging the duration of stay in the bladder and increase the penetration of drug across the bladder wall. IC/BPS, refers to a bladder pain disorder that is often associated with voiding symptomatology and other systemic chronic pain disorders.

We incurred research and development expenses of approximately US$1.6 million and US$1.3 million for the years ended December 31, 2021 and 2022, respectively.

We were incorporated on January 26, 2018 as an exempted company limited by shares under the laws of Cayman Islands. Our registered office is located at 4th Floor, Harbour Place, 103 South Church Street, George Town, P. O. Box 10240, Grand Cayman KY1 1002, Cayman Islands.

Our principal executive offices of our operating subsidiaries are located at 23F-3, No. 95, Section 1, Xintai 5th Road, Xizhi District, New Taipei City, Taiwan, 221. Our telephone number at this address is +886-2-2732-5205. Our principal website is www.healtheverbiotech.com.

Our agent for service of process in the United States is Cogency Global Inc. located at 122 East 42nd Street, 18th Floor, New York, NY 10168.