Mfg News: BeiGene and Sagent

A roundup of manufacturing news from BeiGene and Sagent Pharmaceuticals.

BeiGene Buys Property for New Mfg, Clinical R&D Center
BeiGene, a Beijing-based bio/pharmaceutical company, has closed on the purchase of a 42-acre site in Hopewell, New Jersey to build a new R&D and manufacturing campus.

Subject to finalizing the development plans, BeiGene expects to invest several hundred million dollars in the initial phase of construction. The facility is expected to include up to approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing, including up to 16,000 liters of biologics capacity, along with clinical R&D and office space.

Construction of the initial phase is expected to commence in 2022 and be completed in late-2023 or in 2024. In addition, the property has more than one million square feet of developable real estate for potential future expansion. BeiGene first entered into the purchase agreement for this property in August 2021.

BeiGene, which is partnered with several large bio/pharmaceutical companies, including Amgen and Novartis, has manufacturing operations in Suzhou and Guangzhou, China, for small-molecule drugs and biologics.

In 2020, BeiGene formed two deals with Amgen for $3.2-billion. In January 2020, Amgen formed a global strategic oncology collaboration with BeiGene and took an equity stake in the company for $2.8 billion for the commercialization and development in China of three Amgen oncology drugs: Xgeva (denosumab) for treating giant cell tumors of the bone; Kyprolis (carfilzomib) for treating multiple myeloma; and Blincyto (blinatumomab) for treating relapsed or refractory acute lymphoblastic leukemia. The companies also agreed to collaborate for the joint global development of 20 oncology assets in Amgen’s pipeline with BeiGene responsible for development and commercialization in China. In July 2020, Amgen made an additional investment of $421 million in BeiGene.

Earlier this year (March 2021), BeiGene and Novartis closed on a $2.2-billion licensing agreement and collaboration for tislelizumab, an oncology drug, in major markets outside of China.

Source: BeiGene

Sagent Recalls Seizure Medication Due to Sterility Assurance
Sagent Pharmaceuticals, a subsidiary of the Nichi-Iko Group and manufacturer of pharmaceutical injectables and biosimilars, is voluntarily recalling four lots of levetiracetam injection, USP (500 mg/5 mL) to the user level due to the lack of container-closure integrity found in reserve sample vials, which may result in a non-sterile product.

Levetiracetam injection is used in the treatment of certain types of seizures and is packaged in a 5-mL single-does vial. The product was distributed nationwide from March to November 2021.

Source: US Food and Drug Administration