Orient Pharma Co., Ltd.

Moderna's scrapped mRNA plant in Japan, a negative opinion on Lundbeck and Otsuka's Rexulti, and Pfizer's finalized cancer drug deal with 3SBio made our news this week. Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD treatment was rejected by an FDA advisory committee. Pfizer's PD-1xVEGF deal with 3SBio includes an option agreement. And more.1. Moderna, facing uncertain business environment, scraps plan to establish mRNA plant in JapanModerna has abandoned a plan to construct an mRNA drug substance plant in Fujisawa, Japan. The decision comes “in light of changes in the business environment both globally and in Japan,” the company said. Moderna pledged to continue providing a “stable supply of vaccines to the country using its global manufacturing network.”2. Lundbeck, Otsuka's PTSD bid for Rexulti dealt a setback at FDA advisory committeeAn FDA advisory committee voted 10 to 1 against recommending Lundbeck and Otsuka’s Rexulti, used alongside Viatris’ Zoloft, for treating post-traumatic stress disorder. Even though several experts hinted that the combo may be effective because of a consistent favorable trend observed across trials, they eventually agreed that the evidence wasn't sufficient to draw a conclusion.3. Pfizer finalizes 3SBio PD-1xVEGF deal with China option agreement (release, PDF)Pfizer has finalized its licensing deal for 3SBio’s PD-1xVEGF candidate SSGJ-707. Other than the ex-China portion of the deal featuring a $1.25 billion upfront payment, Pfizer also gained an option to extend the license to cover China. Upon exercise of the option, Pfizer will pay the Chinese company up to $150 million in additional fees.4. TCG Labs Soleil raises $400M for single-asset biotechs, expands R&D footprint to ChinaTCG Labs Soleil has secured $400 million, which is the exact same size as its inaugural fund last year. TCG Labs Soleil runs a venture-biotech model with its own R&D hub, aiming to help single-asset biotechs move through clinical proof of concept. The organization has established an R&D site in Shanghai.5. China’s Novatim licenses BCMA/CD19 CAR-T to Factor’s Erigen (release, Chinese)China’s Novatim has licensed a BCMA/CD19 dual-targeting CAR-T to Erigen, a company associated with Factor Bioscience. The deal includes $15 million in near-term development milestones, with the total milestone payments potentially reaching $1.32 billion. The candidate, coded KQ-2003, is currently in a phase 1b test in China.Other News of Note:6. Orient Pharma, AvKARE recall nearly 80K bottles of cholesterol drug over impurity concerns7. Kyowa, Amgen and Sanofi back push to change websites that miss the mark on women's health8. Roche's Flatiron Health triples cancer network size across UK, Germany and Japan9. Korean CRO CorestemChemon inks collaboration to expand into organoids and transcriptomics

Orient Pharma and AvKARE have each initiated voluntary recalls of the cholesterol-lowering drug pitavastatin, citing failed impurity and degradation tests. Taiwanese drugmaker Orient Pharma and AvKARE of Tennessee have each initiated separate recalls of the high cholesterol drug pitavastatin. Both product pulls have been chalked up to failed impurity and degradation tests.Orient, which launched its recall of 57,504 pitavastatin bottles on June 11, was manufacturing the drug for Teva Pharmaceuticals, according to the FDA's weekly enforcement report. AvKARE, for its part, issued a recall of 10,133 bottles of pitavastatin on June 26. AvKARE's recall covers multiple lots of the drug that were set to expire between Oct. 31, 2025 and Sept. 30, 2026. AvKARE's pitavastatin was shipped nationwide, while the products in Orient's recall were distributed in New Jersey, according to the FDA's recall notice. Both recalls have been logged as Class III, indicating that while FDA regulations have been violated, the products in question are unlikely to cause negative health consequences if used. Statins are one of the most prescribed drugs in the U.S. The CDC estimated that, in 2018, around 92 million adults in the country took statins, representing roughly 35% of adults aged 40 or older.Statins have been subject to recalls in the past, and in at least one instance, impurity concerns were also the culprit. Back in 2021, Dr. Reddy’s recalled hundreds of thousands of bottles of its generic version of Lipitor, atorvastatin, from the market due to impurities in the product. As with Orient and AvKARE, Dr. Reddy's recall was also Class III and covered 10,440 90-count bottles and 224,710 500-count bottles.