On November 1, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with GeneQuantum Healthcare, a China biotech company, to jointly develop an antibody drug conjugate (ADC) for the treatment of non-small-cell lung carcinoma (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors (Press release, Samsung BioLogics, NOV 1, 2020, View Source [SID1234569613]). The agreement signals Samsung Biologics’ accelerated entry into the China market.

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GeneQuantum Healthcare recently received the US FDA’s Investigational New Drug (IND) Good to Proceed Letter in May this year for its first anti-HER2 ADC asset, which was manufactured via GeneQuantum’s patented intelligent ligase-dependent conjugation (iLDC) technology platform.

Samsung Biologics’ approach to entering the Chinese market is strategic. The Chinese biopharmaceutical market was worth 38.5 billion USD in 2019 and is expected to a grow at a rate of 14.4% annually. This new collaboration with a Chinese company follows Samsung Biologics’ recent development partnership with an innovative biotech, APRINOIA Therapeutics, further marking the company’s strategic entry and presence in the market. GeneQuantum had previously signed its CDO contract with a CDMO partner for its first asset, however has notably chosen Samsung Biologics for its second antibody candidate. As a result of Samsung Biologics’ recognized capabilities to achieve best-in-class client satisfaction, the company is currently having extensive discussions with a vast number of potential Chinese clients in the market.

Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for development stage, taking 6 months to DS manufacturing, and 7 months to DP manufacturing. Samsung Biologics has also recently announced its proprietary cell line technology, S-CHOice, in August this year, which shows improved titers up to two-fold from the industry average and maintains over 90% of cell viability.

Owing to these proven features, the company’s CDO business unit has acquired nearly 60 contracts within a 2-year period, gaining recognition in the global market. Through these extended partnerships, especially with leading Chinese biotech companies, Samsung Biologics aims to further demonstrate its high-quality CDO capabilities and technology in the Chinese market to provide greater accessibility to breakthrough treatments for patients.

"GeneQuantum is excited to collaborate with Samsung Biologics, a global leading partner with proven development capabilities in the market," said Dr. Gang Qin, CEO of GeneQuantum. "One of the decision-making aspects for this partnership was Samsung Biologics’ dedication and commitment to providing high-quality services. With this mutually beneficial partnership, we aim to further expand on this development scope to bring innovative treatments for patients."

"We are extremely proud that our CDO capabilities are continuously being recognized in the Chinese market, especially amid the current global climate," said Dr. Tae Han Kim, CEO of Samsung Biologics. "By joining forces with a leading biotech company with a distinguished reputation in the market, we hope to further expand on the partnership to provide effective and affordable treatments for patients with unmet medical needs."

On November 1, 2020 LabCorp (NYSE: LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and BML, a leading Japanese provider of clinical laboratory testing services, reported an expanded agreement to provide development and delivery of companion diagnostics in Japan (Press release, LabCorp, NOV 1, 2020, View Source [SID1234569597]). This collaboration broadens the potential network of laboratories used by pharmaceutical and biopharmaceutical companies to support companion diagnostic development and commercialization. The collaboration is intended to increase access to healthcare providers in Japan, and further accelerate the adoption of companion diagnostics that are used in drug development and clinical trials.

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The collaboration will initially focus on the commercial availability of assays that have been developed and validated both analytically and clinically at LabCorp’s drug development business, Covance. The companies expect the first application of the new agreement will address unmet needs in oncology.
LabCorp is an established leader in the development, validation, and commercialization of companion diagnostics, which are key enablers of precision medicine. The company has been involved in the development of drugs and their associated companion diagnostics for more than 20 years, and has more U.S. Food & Drug Administration-approved companion diagnostics than any other company. BML, a leader in clinical diagnostic testing in Japan, has more than 53 laboratories and 116 customer service locations, and processes more than 1.5 billion diagnostic tests per year.

"Companion diagnostics are a key component of our precision medicine strategy, enabling healthcare providers to identify the patients who are most likely to benefit from targeted and novel therapies," said Steve Anderson, Ph.D., chief scientific officer of Covance and senior vice president at LabCorp. "This partnership with BML further expands our reach to Japan and benefits our biopharmaceutical clients who need global solutions for precision medicine, with the ultimate goal of improving health and improving lives for patients around the world."

"Our collaboration with LabCorp allows BML to provide our clients with robust companion diagnostics services for the patients who need them in Japan. It builds on our trusted relationship with Covance, which has provided clinical trials testing services to our pharmaceutical partners for over 10 years," said Dr. Kensuke Kondo, president of BML. "Our combined ability to bridge the time gaps between the development phase and drug approval through to national reimbursement, along with the benefit of having a centralized laboratory testing facility, gives our respective customers the advantage of early adoption of their drug. BML’s experience with local testing requirements, quality standards and logistical expectations will ensure instant access to high-quality testing."

BML has collaborated with LabCorp’s drug development business Covance for a decade across over a thousand projects. The collaboration created the Covance-BML Trial Laboratory to manage the growing demand for in-country laboratory testing services that support drug development and clinical trials for pharmaceutical companies. Terms of the new agreement have not been disclosed.