I-Mab Expands Antibody Manufacturing for Multiple Myeloma; Pellets had ‘minor observations’ after inspection – Endpoints News


Chinese biopharmaceutical company I-Mab has partnered with Shanghai’s Hangzhou Qiantang New Area to manufacture drugs locally and accelerate the company’s path to commercialization.

The deal will help it commercialize felzartamab, a monoclonal antibody that targets multiple myeloma, in China. Hangzhou began operating at what it calls a phase I site and began construction in December on an 80,000 square meter land 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 affordable, high-quality options to patients through innovative medicines. locally made,” said CCO Yifei Zhu. “This brings us one step closer to our new business model which integrates manufacturing, distribution and sales.”

Multiple myeloma is the second most common hematological malignancy in China, accounting for 1% of all cancers and 13% of all hematological malignancies.

Co-founder Jingwu Zang became interim CEO earlier this year when Joan Shen stepped down to pursue other interests at the end of 2021. The company made headlines in 2020 with a licensing deal of $2.9 billion with AbbVie for its drug CD47, and in September there were reports that the company was considering selling a stake of its own.

Pellets had “minor observations” after inspection

An Indian pharmaceutical company received three observations from the FDA following a pre-approval inspection late last month, the company said.

Granules Pharmaceuticals, in Chantilly, Va., was inspected Jan. 24-28.

“We are pleased to have completed a re-audit with minor observations which we will respond to within the timeframe,” Director Priyanka Chigurupati said in a statement.

The company had an abbreviated new drug application. Approved by the FDA in late January for its bioequivalent potassium chloride treatment of low potassium levels. It has also received approval from its ANDA for bupropion hydrochloride extended-release tablets to treat depression and seasonal affective disorder. This marked the 50th ANDA approval from the FDA.


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