Sunday, August 1, 2021

Fierce Pharma Asia—Serum Institute fire; 2nd Enhertu FDA nod; more Fujifilm expansion

A major fire at the Serum Institute of India’s Pune facility killed five people, while its production of AstraZeneca’s COVID-19 vaccine was unaffected. Daiichi Sankyo and AZ’s Enhertu won its second FDA nod for the treatment of previously treated stomach cancer. On an expansion spree, Fufjifilm has laid out a plan for a new $76 million R&D and manufacturing site in the Boston area. And more.

1. Fire at Serum Institute’s vaccine manufacturing site kills 5 (BBC)

A major fire killed five people at the Serum Institute of India’s (SII’s) vaccine manufacturing facilities in the western Indian city of Pune. The fire happened at a newly constructed building, which includes lab spaces for rotavirus and BCG vaccines. SII is AstraZeneca’s production partner on its COVID-19 vaccine candidate, known locally as Covishield, for low- and middle-income countries. “I would like to reassure all governments & the public that there would be no loss of #COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies” at SII, CEO Adar Poonawalla said in a tweet.

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2. AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer OK

Daiichi Sankyo and partner AstraZeneca won FDA approval for Enhertu in HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s Herceptin. Enhertu cut the risk of death by 41% over chemotherapy in phase 3 trial patients who had progressed on at least two previous treatments. The antibody-drug conjugate is a key pillar in Daiichi’s ambition of achieving JPY500 billion ($5 billion) in peak oncology sales.

3. Fujifilm continues CMDO expansion spree with $76M in funding for new Boston site

A $40 million new viral vector plant and a massive, $2 billion cell culture production site aren’t the only expansions Fujifilm has in mind. The Japanese company, together with The Massachusetts Center for Advanced Biological Innovation and Manufacturing, have put forward $76 million for a 40,000-square-foot site in Watertown. The new facility will support R&D as well as manufacturing work in cell and gene therapy, gene editing, immunotherapy and biotechnology.

4. Adagene plans $125M IPO to go after cancer niches targeted by BMS and Pfizer

Chinese biotech Adagene has filed to raise up to $125 million in a Nasdaq IPO. The company is designing drugs targeting unique binding sites on proteins of interest in cancer. Its most advanced programs include antibodies that target CD137 and CTLA-4.

5. Sinopharm claims COVID-19 vaccine safe in kids aged 3 and up

A clinical trial found a COVID-19 vaccine by Sinopharm’s CNBG to be safe in children aged 3 to 17 years, according to China’s state-run Xinhua. “It should be noted that for 3- to 5-year-old children, because their immune system is still developing, they must be carefully and closely monitored during vaccination,” CNBG Chairman Yang Xiaoming was quoted as saying. CNBG has two inactivated vaccines, and this appears to be the one developed by its Beijing research institute—the same one Chinese authorities conditionally approved at the end of 2020.

6. Samsung eyes manufacturing expansions into U.S. and beyond as work on Korean ‘Super Plant’ plows ahead

Samsung Biologics has a $2 billion “Super Plant” in the works in Incheon, South Korea, but the CDMO is also eyeing manufacturing pushes into the U.S., Europe and eventually, China, newly minted CEO John Rim said at the annual J.P. Morgan healthcare conference. The company’s looking to transfer existing orders to the massive plant and lock in new clients early before its expected 2023 completion date.

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