GenScript Biotech Corporation (Stock Code: 1548.HK) is a global

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

group, founded in

New Jersey New Jersey is a state in the Mid-Atlantic and Northeastern regions of the United States. It is bordered on the north and east by the state of New York; on the east, southeast, and south by the Atlantic Ocean; on the west by the Delaware ...

, United States in 2002, by Dr. Fangliang (Frank) Zhang, Mrs. Ye (Sally) Wang, and Dr. Luquan Wang, and listed on the

Hong Kong Stock Exchange The Stock Exchange of Hong Kong (SEHK, also known as Hong Kong Stock Exchange) is a stock exchange based in Hong Kong. As of the end of 2020, it has 2,538 listed companies with a combined market capitalization of HK$47 trillion. It is repor ...

in 2015. The rotating CEO of GenScript is currently Shao Weihui. GenScript operates in over 100 countries and regions worldwide, with legal entities located in the US, China, Hong Kong, Japan, Singapore, Netherlands, Ireland, the United Kingdom, Korea and Belgium. As of June 30, 2022, GenScript had more than 5500 employees globally. GenScript consists of four major groups: * Life science group

contract research organization In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...

(CRO) and products platforms, which provides customized services and catalog products * Biologics

contract development and manufacturing organization A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organ ...

(CDMO) group * Global

cell therapy Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, for example, by transplanting T-c ...

group * Industrial synthesis product platform ^,

History

GenScript was founded in 2002 in

, and in 2004 established a research and production center in

Nanjing, China Nanjing (; , Mandarin pronunciation: ), alternately romanized as Nanking, is the capital of Jiangsu province of the People's Republic of China. It is a sub-provincial city, a megacity, and the second largest city in the East China region. T ...

. In 2011, the company opened a new Nanjing research and production facility and established a subsidiary in

Japan Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north ...

. In 2013, the company launched a subsidiary called Bestzyme, focused on industrial synthetic biology products, followed by Legend Biotech in 2014, focused on cell therapy. In 2015, GenScript Biotech Corporation was listed on the

under stock code 1548. In 2017, the

China Food and Drug Administration The National Medical Products Administration (NMPA, , formerly the China Food and Drug Administration, or CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the former regulatory body was rebra ...

(CFDA) accepted an investigational new drug (IND) application by Legend Biotech, leading to the establishment of a collaboration on a

B-cell maturation antigen B-cell maturation antigen (BCMA or BCM), also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene. TNFRSF17 is a cell surface receptor of the TNF receptor superfam ...

(BCMA) program between Legend and

Janssen Pharmaceuticals Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen. In 1961, Janssen Pharmaceuticals was purchased by New Jersey-based American c ...

. In 2018, Legend's BCMA program received IND clearance in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

and

China China, officially the People's Republic of China (PRC), is a country in East Asia. It is the world's most populous country, with a population exceeding 1.4 billion, slightly ahead of India. China spans the equivalent of five time zones and ...

. GenScript's Biologics CDMO segment was established shortly thereafter. In 2019, GenScript launched its new Biologics GMP CDMO R&D center and established its European and Asia-Pacific division. Legend's BCMA program received Orphan drug designation (FDA) & PRIME designation (EMA), US phase 1b data at ASH 2019: ORR 100%. In 2020, GenScript and Duke-NUS Medical School co-developed a cPass sVNT kit, first in the world

SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...

serology test to detect neutralizing antibodies. Legend Biotech was listed on

NASDAQ The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...

under stock code LEGN. GenScript participated as a sponsor of the 2021 International Genetically Engineered Machine Synthetic Biology Competition (iGEM).

Operations

GenScript owns a number of intellectual property rights and trade secrets, Including over 190 patents, over 820 pending patent applications.

GenScript Life Science Group

GenScript Life Science Group is GenScript's original business unit. Based on its independent and leading gene synthesis technology, the GenScript Life Science business has grown to become the world's largest gene synthesis provider with a market share of approximately 30%. As of June 30, 2022, over 74,700 peer-reviewed journal articles worldwide have cited GenScript Biotech's services and products.

GenScript ProBio – Bio-pharmaceutical CDMO

GenScript ProBio is the bio-pharmaceutical CDMO segment, which has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions., As of September, 2022, GenScript ProBio assisted the clients in receiving 37 IND approvals.

Legend Biotech – Cell Therapy

A a subsidiary of GenScript Biotech Corporation, Legend Biotech (NASDAQ: LEGN) is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncological and other indications. Legend Biotech's team includes over 650 employees across the United States, China and Europe. Along with differentiated technology, development, and manufacturing strategies and expertise, Legend Biotech is engaged in the discovery, development, and manufacturing of cell therapies for patients in need. Legend Biotech has established a strategic collaboration with

Janssen Biotech Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen. In 1961, Janssen Pharmaceuticals was purchased by New Jersey-based American ...

to develop and commercialize the lead product candidate, LCAR-B38M/JNJ-4528, an investigational BCMA-targeted

CAR-T In biology, chimeric antigen receptors (CARs)—also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors—are receptor proteins that have been engineered to give T cells the new ability to target a specific ...

cell therapy for patients living with relapsed or refractory

multiple myeloma Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, an ...

. This candidate is currently being studied in registrational clinical trials.

Bestzyme – Industrial Synthesis Product

Nanjing Nanjing (; , Mandarin pronunciation: ), alternately romanized as Nanking, is the capital of Jiangsu province of the People's Republic of China. It is a sub-provincial city, a megacity, and the second largest city in the East China region. T ...

Bestzyme Bioengineering Co., Ltd. (Bestzyme), is one of GenScript's subsidiaries integrating the development of enzyme preparations and the development, production, and sales of enzyme catalysis technology for active product ingredients (APIs).

References

{{reflist Companies listed on the Hong Kong Stock Exchange Biotechnology companies of the United States Companies established in 2002 Companies based in Middlesex County, New Jersey Piscataway, New Jersey