Oncogen Pharma & BrightGene Bio-Medical Technology announced agreement signing to develop, manufacture, market, & distribute Generic products for U.S.A market.
SHAH ALAM, SELANGOR, MALAYSIA, June 14, 2021 /EINPresswire.com/ — Oncogen Pharma (Malaysia) Sdn Bhd a Malaysia-based generic pharmaceutical manufacturer and BrightGene Bio-Medical Technology Co., Ltd (Shanghai Stock Exchange Stock code: 688166) from China, have announced signing of an agreement to develop, manufacture, market, and distribute Generic products for the United States market. The initial partnership agreement signed between the two companies includes one complex generic product under Oncology segment, which has already completed the development process. Under the terms of this agreement, the expertise of each company will be leveraged to create a highly efficient and effective product flow, from active pharmaceutical ingredients (API) manufacturing through to regulatory approval and distribution, that will bring high quality generic drugs to the USA market over the next few years.
Rahil Mahmood, Chief Executive Officer of Oncogen Pharma said, “We are pleased to announce our strategic partnership with BrightGene Bio-Medical Technology to accelerate the development and manufacturing of oncology product for patients in the U.S.A market. The combination of the two companies’ development and manufacturing capabilities represent yet another step in our unwavering commitment towards developing and providing access to high quality, affordable and innovative medications to patients in the U.S.A and to put Malaysia on the global map of innovative pharmaceutical development”.
The product selection committee, made up of 3 members from each company, has chosen the first product to build a balanced offering in the Oncology category, providing potential customers with a single source for the most important molecules of the category.
Oncogen’s responsibilities within the partnership will include product development, filing the abbreviated new drug applications (ANDAs) for USFDA approval and commercial launch of the products in USA market. Manufacturing for these products will be carried out at its Oncology facility in Malaysia for export to the USA.
For additional group of products, Oncogen and Brightgene have already begun to identify several more products to pursue in the complex generic category for various therapeutic areas. The two companies fully expect this agreement to expand significantly in the short term and for it to last for many years.
About Oncogen Pharma (Malaysia) Sdn Bhd
Oncogen Pharma (Malaysia) Sdn Bhd is a fully integrated research based pharmaceutical company with a global outlook towards cancer treatment. Based in Malaysia, it is one of the fastest growing Pharmaceutical companies in the country with the largest portfolio of Oncology products under development. Oncogen Pharma has established the most advanced R&D facilities for developing Oncology APIs and formulations for regulated markets. The diversified and qualified technical team of top professionals from different parts of the world have deep experience & exposure of the development of strategic products for global markets.
Oncogen’s API and Formulation plants are set-up close to each other on over 6 acres of land in Bandar Enstek Park, Negeri Sembilan, Malaysia and are designed by international experts following stringent regulatory requirements by authorities across the globe including USFDA, EMA, PIC/S and WHO.
Oncogen has undertaken to launch its global products in Malaysia starting from mid 2022 to make high quality cancer treatment affordable and accessible for the cancer patients.
BrightGene Bio-Medical Technology Co., Ltd. is a public listed China-based company mainly engaged in chemical pharmaceutical business. The company is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with high-tech barriers having a primary strategic focus on the regulated markets.