Industry News

Mirogabalin besylate is a gabapentinoid developed by Daiichi Sankyo Co., Ltd. in Japan. In January 2019, it was approved for marketing in Japan for the treatment of peripheral neuropathic pain, including diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), under the trade name Tarlige.

Mitapivat was developed by Agios Pharmaceuticals, an American pharmaceutical company, and is approved in the European Union and the United States as an oral treatment for hemolytic anemia and pyruvate kinase deficiency (PKD), a rare inherited disorder associated with chronic hemolytic anemia. In addition to the approved PKD indication, it is currently undergoing clinical studies for the treatment of sickle cell disease and thalassemia.

As pharmaceutical manufacturers continue to focus on reliable sourcing of active pharmaceutical ingredients (APIs), quality consistency and supply stability remain important considerations when selecting local anesthetic materials. Ropivacaine Hydrochloride is an important pharmaceutical ingredient used in the development and manufacture of local anesthetic products.

Currently, the first-line drug for the treatment of PBC is ursodeoxycholic acid (UDCA), and the second-line drug obeticholic acid (OCA) has been withdrawn from the market due to efficacy issues. In 2024, the FDA approved the dual PPARα/δ agonist Elafibranor and the selective PPARδ agonist Seladelpar. Linerixibat is the first and currently the only drug specifically approved for pruritus in PBC. Other drugs mainly target disease progression or biochemical indicators, which provides more options for PBC patients.

Merck, in collaboration with Huanquan and Conquer Biotech, publicly disclosed the total synthesis of MK-0616, a first-in-class oral macrocyclic peptide PCSK9 inhibitor for cardiovascular disease. Facing structural complexity, the team developed a scalable route through multi-generation optimization—reducing steps from 63 to 43 and linear sequence from 28 to 21 steps. Key innovations include biocatalysis (KRED, TrpB, hydroxylase), crystallization-driven purification (avoiding chromatography), and orthogonal protecting group strategies. The second-generation process achieves nearly 1,000-fold yield improvement, enabling ton-scale production while significantly lowering costs, setting a benchmark for complex macrocyclic peptide synthesis.