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Subjects: CON, LIC, TRI, FDA, IMA

OncoVent, a Subsidiary of Hepalink, Enters into a License and Distribution Agreement with Orient EuroPharma for the Immunotherapeutic Candidate Oregovomab

SHENZHEN, China, March 28, 2023 /PRNewswire/ -- OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP").

According to the terms of the agreement, OncoVent agreed to grant exclusive rights to OEP, which will be responsible for the commercialization of oregovomab, an immunotherapy drug candidate, in Taiwan, including related regulatory applications and necessary clinical trials. OncoVent is entitled to a number of payments from OEP under the license agreement, including a one-off non-refundable upfront payment upon the effective date of the license agreement, multiple regulatory milestone payments, and multiple commercial milestone payments, in a total transaction amount of up to US$11.2 million. OEP also agreed to purchase oregovomab from OncoVent at a price equal to an agreed percentage to the average sale price of oregovomab in Taiwan.

In addition, OncoVent granted OEP the right of first refusal for the exclusive sales, marketing, and distribution right in Hong Kong and Macau.

Oregovomab, a murine monoclonal antibody and a first-in-class anti-CA125 immunotherapy drug candidate, is currently being evaluated in a global Phase III trial using study drugs produced by Cytovance Biologics Inc, a wholly-owned subsidiary of the Company and a leading contract development and manufacturing organization (CDMO) serving the biopharmaceutical industry.

Prior to this, a Phase II clinical study of oregovomab in combination with standard chemotherapy for the first-line treatment of patients with advanced primary ovarian cancer was already completed. Results from the Phase II clinical trial showed that the safety and efficacy of the combination in patients with advanced primary ovarian cancer were in line with expectations, with the median progression-free-survival (PFS) of the oregovomab plus chemotherapy cohort significantly improved to 41.8 months, compared with 12.2 months with the chemotherapy-only regimen, with a hazard ratio (HR) of 0.46 (95% confidence interval [CI]: 0.28, 0.77). It also showed a significant improvement in overall survival (OS) with an HR of 0.35 (95% Cl: 0.16, 0.76).

Ovarian cancer is ranked the eighth most common cancer in women globally and the first-line treatment for this disease has not changed for many years. Oregovomab has obtained Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The first patient in a Phase III clinical trial of oregovomab was dosed in the U.S. in 2020. This global pivotal trial is expected to enroll 602 patients from 190 clinical sites in 17 countries and regions. As of the date of the announcement, the Phase III clinical trial of oregovomab has enrolled 534 subjects globally, of which 21 subjects are from Taiwan.

Mr. Calvin Tsai, Chief Executive Officer of OEP, said, "we have been actively expanding our oncology portfolio through R&D collaborations and in-licensing, in order to address unmet medical needs in a broad range of tumor types and bring renewed hope to cancer patients in the Asia Pacific region. Hepalink is a leading multinational biopharmaceutical company dual-listed in Hong Kong and mainland China. Its subsidiary, OncoVent, possesses a monoclonal antibody (mAb) technology platform and advanced biotechnologies for the development of oncotherapeutic vaccines and immuno-oncologic combination therapies. It is our pleasure to enter into this collaboration with Hepalink. We believe oregovomab can potentially improve the treatment outcomes for patients with advanced primary ovarian cancer. This collaboration with OncoVent not only strengthens our oncology portfolio, but also serves our overarching objective of advancing oncologic therapeutics."

Ms. Tao Han, Chief Business Officer of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. and Chief Executive Officer of OncoVent Co., Ltd, commented, "having established itself in the oncology field for over 20 years, OEP is a multinational pharmaceutical company with integrated capabilities in R&D, manufacturing and commercialization, as well as a highly experienced team in the Asia Pacific region. We are glad to have entered into this strategic agreement with OEP as it will allow us to jointly develop and commercialize oregovomab, a candidate drug with promising therapeutic potential, and explore the drug's additional therapeutic utility for a broader population of cancer patients. Moving forward, Hepalink will continue to seek partnering opportunities to accelerate the expansion of its innovative drug business and develop a diverse range of commercial capabilities."

About Orient EuroPharma

Established in 1982 and officially listed on the Taipei Exchange in 2003, OEP provides prescription drugs, cancer drugs, nutrition and healthcare for young children and adults, medical and beauty care and other products. It has research and development centers in Taiwan and the United States, and two pharmaceutical factories in Taiwan for U.S. FDA-approved oral finished doses and highly allergenic injections. It is a multinational pharmaceutical manufacturer with research and development, production and sales capabilities as well as sales teams covering Southeast Asia, Hong Kong, Mainland China and the United States. With over 20 years of experience in the cancer field and solid business and sales teams in Taiwan, Hong Kong, Singapore, the Philippines and Malaysia. OEP currently sells cancer drugs such as "Vinorelbine" oral capsules for non-small cell lung cancer and breast cancer, and "Pamorelin" long-acting injections for prostate cancer.

About OncoVent

OncoVent Co., Ltd. was established in July 2016 and located in the Shenzhen Qianhai Development Zone. OncoVent is leveraging its technology platform of monoclonal antibodies (mAb) to develop clinical-stage therapeutic vaccines and immuno-oncology combination therapies. At present, a number of the OncoVent's drug candidates are already in clinical development.

About Hepalink

Established in 1998 in Shenzhen, China, Hepalink (002399.SZ, 09989.HK) is a leading multinational biopharmaceutical company dual-listed in Hong Kong and mainland China, with its core business in heparin industrial chain, large molecule biologics CDMO services, and the research, development, and commercialization of innovative drugs. These three synergistic business segments are driven by the mission of addressing patients' unmet medical needs and bringing safe and effective therapies and services to patients around the world. To learn more, please visit: http://www.hepalink.com/

SOURCE Shenzhen Hepalink Pharmaceutical Group Co., Ltd.

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