Sun Pharmaceutical Industries Ltd.

Johnson & Johnson's manufacturing pact with Fujifilm Biotechnologies, three Indian companies' drug recalls, and an eye disease deal between Santen Pharmaceutical and RemeGen made our news this week. Johnson & Johnson is spending part of its big U.S. investment at a Fujifilm Biotechnologies site. Three Indian drugmakers issued U.S. drug recalls in recent weeks due to impurities. Japan's Santen Pharma licensed a VEGF/FGF bispecific from RemeGen. And more.1. In US manufacturing push, J&J earmarks $2B for Fujifilm in 10-year deal in North CarolinaJohnson & Johnson has committed $2 billion over the next 10 years to secure a 160,000-plus-square-foot facility at Fujifilm Biotechnologies’ biomanufacturing campus in Holly Springs, North Carolina. The deal will create about 120 new jobs in the state, J&J said. The pact followed a $3 billion arrangement Fujifilm recently made with Regeneron.2. Alembic, Sun and Glenmark issue US drug recalls due to the presence of carcinogens or foreign matterThree Indian drugmakers—Alembic, Sun Pharma and Glenmark—have issued separate U.S. drug recalls in recent weeks. Alembic recalled 9,492 bottles of doxepin hydrochloride due to an impurity of the potential human carcinogen nitrosamine. In addition, Sun recalled 11,328 bottles of spironolactone due to the presence of aluminum, and Glenmark issued three recalls, including two covering carvedilols because of the presence of a nitrosamine.3. China's RemeGen sells Asia rights to VEGF/FGF eye drug in $180M dealJapanese eye disease specialist Santen Pharmaceutical is paying 250 million Chinese yuan ($34.8 million) for certain Asia rights to a VEGF/FGF fusion protein by China’s RemeGen. The drug, coded RC28-E, is already in phase 3 development in diabetic macular edema and wet age-related macular degeneration. The deal could eventually be worth about $180 million.4. GC’s Made Scientific opens cell therapy facility in New Jersey (release)Made Scientific, a U.S.-based cell therapy CDMO subsidiary of Korea’s GC Holdings, has opened its 60,000-square-foot facility and headquarters in Princeton, New Jersey. The opening marked the completion of a $12 million initial investment in the site. The company plans to add 12,000 square feet in additional clean room space to support late-stage and commercial programs.

2025年8月21日，艾伯维AbbVie宣布，其研发的口服JAK1抑制剂Rinvoq（upadacitinib）在治疗斑秃的第二项关键三期临床试验（UP-AA项目中的研究1）中取得了积极的顶线结果。 试验结果令人鼓舞 在该项试验中，Rinvoq的两种剂量（15mg和30mg，每日一次）均达到了主要终点。结果显示，接受15mg和30mg Rinvoq治疗的严重斑秃患者中，分别有45.2%和55.0%在第24周时头皮毛发覆盖率达到了80%或以上（SALT评分≤20），而安慰剂组的这一比例仅为1.5%。 此外，关键次要终点也均得以实现，包括眉毛和睫毛的改善，以及在第24周头皮覆盖率达到90%或以上（SALT≤10）和完全覆盖头皮毛发（SALT=0）的受试者百分比。 这些结果与7月30日公布的3期UP-AA临床项目的第一个平行重复研究（研究2）的顶线结果一致。 在安全性方面，Rinvoq在斑秃治疗中的安全特征总体上与批准的适应症一致，本研究未发现新的安全信号。在乌帕替尼 15 毫克组和 30 毫克组中，治疗期间出现的严重不良事件分别发生在 1.9% 和 1.8% 的患者中，而安慰剂组为 0.7%。因治疗期间出现的不良事件（TEAEs）而停药的患者比例分别为：乌帕替尼 15 毫克组 1.1%，乌帕替尼 30 毫克组 1.5%，安慰剂组为 0。 最常见的治疗期间出现的不良事件为上呼吸道感染、痤疮、血肌酸磷酸激酶升高和鼻咽炎。严重感染报告较少，安慰剂组和乌帕替尼 30 毫克组各报告 1 例，乌帕替尼 15 毫克组无报告。未报告经判定的主要不良心血管事件、经判定的静脉血栓栓塞事件或死亡病例。在15毫克组中报告了一例恶性肿瘤（乳腺癌）。 斑秃是一种自身免疫性疾病，会导致患者头皮、脸部甚至全身毛发脱落，严重影响患者身心健康和生活品质。目前治疗斑秃的选择有限，疗效也因人而异。而Rinvoq作为一种新型的JAK抑制剂，其作用机制在于抑制参与免疫反应的特定激酶，从而控制炎症反应，达到治疗斑秃的效果。 结束语： 此次第二项三期临床试验的成功，进一步证实了Rinvoq在治疗斑秃方面的潜力和价值。艾伯维公司计划将这些数据提交给美国及其他地区的监管机构，以扩大Rinvoq的治疗适应症。 目前全球获批用于斑秃JAK抑制剂括辉瑞的利特昔替尼胶囊(LITFULO®)、礼来的巴瑞替尼片(OLUMIANT®)、 Sun Pharmaceutical Industries 的 Deuruxolitinib 片(LEQSELVI™)，以及恒瑞的硫酸艾玛昔替尼等

AbbVie's Rinvoq has posted phase 3 results that suggest it can be a highly effective treatment for alopecia areata. The company said it will submit results to regulatory authorities. For the second time in the last three weeks, AbbVie has revealed successful results from a phase 3 study of Rinvoq as a treatment for the hair-loss disease alopecia areata (AA).The second replicate study in the AbbVie trial program achieved its primary endpoint, as 45.2% and 55% of patients who received respective 15 mg and 30 mg daily doses of Rinvoq reached 80% or more of scalp coverage after 24 weeks. The results were similar to those from a parallel study—with the same parameters—in which 44.6% and 54.3% of patients achieved the scalp coverage standard.Nearly 1,400 patients enrolled in the studies at a baseline mean of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said. In the newly reported study, 1.5% patients who received placebo reached the 80% coverage standard, while in the parallel study, 3.4% of patients on placebo hit that mark.“We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies,” Kori Wallace, M.D., Ph.D., AbbVie’s global head of immunology clinical development, said in a statement.Additionally, in the recent study, 35% and 46% of patients treated with 15 mg and 30 mg daily doses of Rinvoq, respectively, reached 90% or more of scalp coverage at week 24. This result compared with 0.7% for those on placebo.As for secondary endpoints, both studies achieved their objectives in eyebrow and eyelash improvements. Another secondary objective that was achieved in both studies was the number of patients in each dosage group who gained complete scalp coverage at week 24.The safety profile of both doses of Rinvoq was consistent with that observed in approved indications, AbbVie said. While cross-trial comparisons are often problematic, Rinvoq appears to provide better results than three other JAK inhibitors currently on the market in the indication.The most recently approved treatment for alopecia, Sun Pharma’s Leqselvi, was tested in 1,220 patients in two trials who had a mean baseline scalp coverage of 13%. At the 24-week mark, more than 30% of patients saw their scalp coverage increase to at least 80%.Eli Lilly’s Olumiant was approved in 2022 for alopecia based on trials that showed between 17% and 22% of patients taking a 2 mg daily dose achieved 80% scalp coverage after 36 weeks, while 32% to 35% of patients taking a 4 mg daily dose reached the same standard. Pfizer’s Litfulo was approved in 2023 after a study showed 23% of patients reached 80% or more of scalp coverage after six months of treatment. Last month, AbbVie reported Rinvoq’s second-quarter sales at $2.03 billion, a 42% year-over-year increase. The product generated $5.97 billion in revenue last year.The treatment hit the market in 2019 to treat patients with rheumatoid arthritis. Since then, it has been cleared in several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease and ulcerative colitis.