I-Mab expands manufacturing for multiple myeloma antibody; Granules issued 'minor observations' after inspection
China-based biopharma I-Mab has landed a partnership with Shanghai’s Hangzhou Qiantang New Area to manufacture drugs locally and speed up the company’s path toward commercialization.
The deal will help it commercialize felzartamab, a monoclonal antibody that targets multiple myeloma, in China. Hangzhou has started operating on what it calls a Phase I site and started construction in December on an 80,000 square-meter spot for Phase II.
“Today’s announcement demonstrates the Company’s commitment to translating our scientific innovation into clinical and commercial value as soon as possible so that we can provide more high-quality, affordable options for patients through locally-manufactured, innovative drugs,” CCO Yifei Zhu said. “This brings us one step closer to our new commercial model that integrates manufacturing, distribution and sales.”
Multiple myeloma is the second most common hematologic malignancy in China, making up 1% of all cancers and 13% of all blood malignancies.
Co-founder Jingwu Zang became the acting CEO at the start of the year when Joan Shen stepped down to pursue other interests at the close of 2021. The company made headlines in 2020 with a $2.9 billion licensing deal with AbbVie for its CD47 drug, and in September, there were reports the company was considering selling a stake of itself.
Granules issued ‘minor observations’ after inspection
An Indian pharma was issued three observations by the FDA, following a pre-approval inspection at the end of last month, the company said.
Granules Pharmaceuticals, in Chantilly, Virginia, was inspected from Jan. 24-28.
“We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period,” director Priyanka Chigurupati said in a statement.
The company had an abbreviated new drug application. Approved by the FDA at the end of January for its potassium chloride bioequivalent treatment of low potassium levels. It also received approval for its ANDA for Bupropion Hydrochloride extended-release tablets to treat depression and seasonal affective disorder. That marked the 50th ANDA approval from the FDA.