Fierce Pharma Asia—Plant expansions at Novo, Novartis, Merck KGaA; Kyowa Kirin's pricing record; BeiGene's PD-1 nod

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来源: FiercePharma

New investments in biopharma manufacturing by Novo Nordisk, Novartis and Merck KGaA; Kyowa Kirin's $4.25 million gene therapy; and BeiGene's belated PD-1 approval made our news this week.

Three large pharma companies plan to expand their manufacturing footprints. Kyowa Kirin’s $4.25 million gene therapy set a new world pricing record. BeiGene’s PD-1 inhibitor finally crossed the FDA finish line after a 20-month delay. Plus more headlines.

1. Riding GLP-1 wave, Novo Nordisk lays out $560M to boost drug production in China

Celebrating its 30th anniversary in China, Novo Nordisk unveiled a 4 billion yuan ($556 million) investment to expand its flagship factory in Tianjin. The project, which will improve the process for producing sterile drugs, has already kicked off and is expected to be complete in 2027. Novo’s obesity blockbuster, Wegovy, is expected to win approval in China later this year.

2. Novartis lays out $256M for antibody plant expansion in Singapore, plots 100 hires

Novartis broke ground on a $256 million expansion of its biologics facility in Singapore. Like many other recent Novartis projects, the Singapore plant will feature digitalization and automation. The expanded site is expected to come online in 2026 and will create 100 new jobs.

3. Merck KGaA's MilliporeSigma drops €300M on Korean biologics plant with plans to create 300 new jobs

Merck KGaA has chosen South Korea as the latest location to expand its life sciences service unit, MilliporeSigma. In the unit’s largest investment in the Asia-Pacific region to date, MilliporeSigma is pouring 300 million euros ($326 million) into a new bioprocessing plant in Daejeon. The project is expected to create 300 new jobs by the end of 2028.

4. After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US

Orchard sets new gene therapy price tag at $4.25M—the steepest of any drug

Kyowa Kirin’s Orchard Therapeutics has won FDA approval for Lenmeldy, the first gene therapy for the rare central nervous system genetic disease metachromatic leukodystrophy. The product uses the patient’s own hematopoietic stem cells to deliver functional copies of the ARSA gene. Orchard has set the list price for the one-time therapy at $4.25 million, making it the most expensive drug in the world.

5. BeiGene finally snags FDA approval for PD-1 drug Tevimbra after long delay, Novartis breakup

Twenty months after the FDA’s original target decision date, BeiGene’s PD-1 inhibitor Tevimbra finally won the go-ahead to treat post-chemo advanced esophageal squamous cell carcinoma. The company will launch the drug in the second half of the year, and its first-line application is awaiting an FDA verdict in July.

6. Despite early death concerns, FDA advisers back J&J and Legend's Carvykti and BMSBMS' Abecma for earlier myeloma

Eleven experts on the FDA’s Oncologic Drugs Advisory Committee voted unanimously in favor of Johnson & Johnson and Legend Biotech’s Carvykti in second-line multiple myeloma. Despite the agency’s concerns about an increased risk of death in the first few months of a clinical trial, the experts agreed that the CAR-T therapy’s benefits over a longer time frame outweigh the risks.

7. WuXi AppTec still sees sales growing and expansions rolling in 2024 despite concerns over US biosecurity bill

WuXi AppTec doesn’t expect the draft BIOSECURE Act targeting it and other Chinese biotechs to materially affect its business in 2024. The company reported 2023 revenue at 40.34 billion yuan ($5.6 billion), including 65% from its customers in the U.S. For 2024, WuXi AppTec expects revenues to land within 38.3 billion yuan to 40.5 billion yuan, growing between 3% to 9% after excluding COVID projects.

Other News of Note:

8. Takeda's Iclusig wins first-line FDA nod to treat rare Philadelphia chromosome-positive ALL

9. Hansoh, fresh from Big Pharma deal table, signs $690M ADC pact with Biotheus

10. Chinese biotech's MASH candidate reduces liver fat in phase 2 trial

11. Innovent's anti-VEGF drug matches Eylea in phase 2 eye disease trial

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