Workflow
Pharmaceuticals
icon
Search documents
CMS (867.HK/8A8.SG): Innovative Drug Oral JAK1 Inhibitor Povorcitinib Has Been Included in the List of Breakthrough Therapeutic Drugs in China
Globenewswire· 2025-12-15 13:19
Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, has obtained licensing rights for the innovative oral JAK1 inhibitor povorcitinib, which is aimed at treating non-segmental vitiligo and has been recognized as a Breakthrough Therapeutic Drug by the NMPA, potentially expediting its development and review process in China [1][6]. Group 1: Product Development and Clinical Trials - Povorcitinib is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa, and prurigo nodularis in various countries outside China, with a Phase 2 trial for asthma also in progress [2]. - In March 2023, Incyte reported that povorcitinib met the primary endpoint in a global Phase 2b trial for non-segmental vitiligo, showing significant improvement in total body repigmentation after 24 weeks of treatment [3]. - Dermavon received approval from the NMPA in August 2025 to conduct clinical trials for povorcitinib in China, with plans to explore additional indications for skin-related diseases in the future [4]. Group 2: Market Potential and Patient Impact - Vitiligo affects approximately 10.3 million patients in China, with around 8.2 million suffering from non-segmental vitiligo, highlighting a significant unmet medical need for effective treatments [5]. - If approved, povorcitinib could offer a differentiated treatment option for non-segmental vitiligo patients, particularly those with moderate to severe forms of the disease [5]. - The inclusion of povorcitinib in the Breakthrough Therapeutic Drugs list is expected to enhance its clinical and commercial value, potentially benefiting patients with skin diseases through synergy with other Dermavon products [6]. Group 3: Collaboration and Licensing - Dermavon entered into a Collaboration and License Agreement with Incyte on March 31, 2024, granting exclusive rights to develop and commercialize povorcitinib in several regions, including Mainland China and Southeast Asia [7].
Earth Science Tech, Inc. Receives FINRA Clearance on Form 211 to Initiate Quotations
Globenewswire· 2025-12-15 13:00
Core Insights - Earth Science Tech, Inc. (ETST) has received clearance from the Financial Industry Regulatory Authority (FINRA) for its Form 211 application, allowing for the initiation of priced quotations for its securities [1][2][3] Company Overview - ETST operates as a strategic holding company focused on acquiring and scaling high-potential operating businesses, with current operations in compounding pharmaceuticals, telemedicine, and real estate development through various subsidiaries [3] - The company's subsidiaries include RxCompoundStore.com, Peaks Curative, Avenvi, Mister Meds, Earth Science Foundation, Las Villas Health Care, and an 80% interest in MagneChef [3] Subsidiary Highlights - **RxCompoundStore.com, LLC**: A fully licensed compounding pharmacy operating in multiple states, actively pursuing licensure in remaining U.S. states [4] - **Mister Meds, LLC**: A compounding pharmacy in Texas with advanced sterile compounding capabilities, applying for licensure in additional states [5] - **Peaks Curative, LLC**: A telemedicine platform offering consultations for compounded medications, expanding into the veterinary market through the acquisition of Zoolzy.com [6] - **Las Villas Health Care, Inc.**: A healthcare facility focused on the Spanish-speaking community, providing advanced health treatments [8] - **Avenvi, LLC**: A diversified real estate company managing a $10 million share repurchase program and overseeing investment activities for ETST [9] - **MagneChef**: A direct-to-consumer retail brand developing new cooking products and expanding into the BBQ tool market through the acquisition of BBQraft [9] - **Earth Science Foundation, Inc.**: A nonprofit organization providing financial support for prescription costs at ETST's pharmacies [10] Strategic Importance - The clearance of Form 211 is viewed as a critical milestone for ETST, expected to enhance shareholder value, improve liquidity, and provide greater visibility for executing its business plan [3]
Amphastar Announces FDA Approval for Teriparatide Injection
Accessnewswire· 2025-12-15 11:00
Core Viewpoint - Amphastar Pharmaceuticals, Inc. has received FDA approval for its teriparatide injection, which is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO® [1] Company Summary - Amphastar Pharmaceuticals announced the approval of its Abbreviated New Drug Application (ANDA) for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen [1] - The FDA's determination confirms that Amphastar's teriparatide is equivalent to Eli Lilly's product, indicating a significant milestone for the company in the competitive pharmaceutical market [1] Industry Summary - The approval of teriparatide injection highlights the ongoing developments in the pharmaceutical industry, particularly in the area of biosimilars and generic drugs [1] - The bioequivalence to a well-established product like FORTEO® may enhance market competition and provide more options for patients [1]
Sanofi shares slide as FDA delays MS drug decision and late-stage trial disappoints
Invezz· 2025-12-15 10:48
Core Viewpoint - Shares of French pharmaceutical group Sanofi experienced a significant decline following the announcement of another delay in the US regulatory decision for its experimental multiple sclerosis drug tolebrutinib [1] Group 1 - Sanofi's stock price fell sharply on Monday due to the regulatory delay [1] - The delay pertains to the US regulatory decision regarding the multiple sclerosis drug tolebrutinib [1]
创新药保障“最后一公里”待解:买得到、赔得快、保得起
Core Insights - The release of the 2025 National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory marks a significant milestone in China's healthcare payment system, transitioning to a dual-driven model of "basic medical insurance + commercial health insurance" [1][3][10] Group 1: Policy Changes - The new policies clarify the payment boundaries between government and market, with the Commercial Health Insurance Innovative Drug Directory focusing on high-value innovative drugs that exceed the basic medical insurance coverage [3][4] - The 2025 Medical Insurance Directory adds 114 new drugs, achieving a negotiation success rate of 88.19%, the highest in seven years, with a total of 3,253 drugs now covered [3][4] Group 2: Drug Inclusion - The first Commercial Health Insurance Innovative Drug Directory includes 19 drugs, such as CAR-T therapies and new Alzheimer's medications, which are typically expensive and risky, thus not included in basic medical insurance [4][5] - Five CAR-T therapies have been included in the directory, representing over half of the currently available products in China, with prices exceeding 1 million yuan for most [5][6] Group 3: Market Dynamics - The dual-track system addresses the affordability of high-value drugs for patients while providing a sustainable return mechanism for pharmaceutical companies, thus driving high-quality development in China's innovative drug industry [4][6] - The introduction of these directories is expected to enhance clinical medication levels and overall R&D returns, particularly benefiting leading innovative pharmaceutical companies with extensive pipelines [6][7] Group 4: Consumer Impact - The integration of the two directories allows for a complementary relationship, where commercial insurance can cover innovative drugs first before they are potentially included in basic medical insurance [7][8] - The "gradient payment" mechanism enables patients to access the latest therapies without facing the dilemma of full out-of-pocket expenses, as commercial insurance will provide payment support [8][10] Group 5: Implementation Challenges - There are practical challenges in ensuring that hospitals stock the newly included high-priced drugs, as they may face financial disincentives to do so [10][11] - The claims process for commercial insurance may still require patients to pay upfront, which can be a significant burden for high-cost innovative drugs [10][11] - The potential for increased claims rates due to the inclusion of high-risk drugs may lead to higher insurance premiums or stricter underwriting standards in the future [12]
速递|麻省理工:每周减重1%,瘦体重全保留
GLP1减重宝典· 2025-12-15 10:43
整理 | GLP1减重宝典内容团队 一种每日一次口服的减重药物,正被视为注射类GLP-1减肥药之外的更易获得选择。美国生物科技公司Syntis Bio近日宣布,已完成 3800万美元融资,用于加速其口服减重药的研发进程。该药物通过模拟胃旁路手术的生理效果,在不进行侵入性手术的情况下,帮助调 节食欲与代谢。 Syntis Bio总部位于波士顿,本轮融资中,公司完成了3300万美元A轮融资,资金将用于推进核心产品Synt-101的开发,同时还获得了 最高500万美元的非稀释性科研资助。 Synt-101是一款每日服用一次的口服制剂,其作用机制并非直接抑制食欲,而是暂时阻断小肠上段对营养的吸收,并将营养物质重新引 导至下段,从而激活人体自身释放调节饱腹感和代谢的激素反应。该产品基于公司自主研发的"Synt"合成组织内衬技术,通过类似贻贝 黏附机制的涂层,在小肠内形成可持续约24小时的功能性覆盖层。 尽管当前研发重点集中在减重领域,Syntis Bio认为,这一技术平台具备高度延展性,未来可应用于多种疾病治疗场景。 公司披露的临床前数据显示,在动物模型中,Synt-101实现了每周约1%的稳定体重下降,同时瘦体重保持 ...
“纯度99%”磷虾油竟无磷脂?同仁堂涉嫌造假被约谈,百年老字号贴牌成灾?
新浪财经· 2025-12-15 10:41
文 | 《BUG》栏目 张俊 百年老字号同仁堂陷入了造假风波。 上海市消保委近日表示,一款同仁堂 99% 高纯南极磷虾油产品,却检测出磷脂含量为 0 ,涉嫌造假。上海市消保委称将约谈该产品的经销商北京同仁堂(四川)健康药业有限公 司。 工商资料显示,北京同仁堂(四川)健康药业有限公司是同仁堂集团的"孙字辈企业"。但 《 BUG 》栏目致电同仁堂集团官网电话,工作人员称"我们没有这款产品"。 实际上,同仁堂一直存在着贴牌乱象。虽然同仁堂集团多次在官网发布声明称从未允许下属 公司使用"同仁堂"商标或者字样,但线上平台上的贴牌产品却层出不穷。 同仁堂的业绩压力,或许是子品牌们热衷于贴牌的原因之一。根据同仁堂股份日前发布的财 报显示,其今年前三季度营收和净利双双陷入下滑。 今年 8 月,张朝华接任同仁堂股份董事长一职。根据同仁堂股份 2024 年财报显示,张朝 华当年的报酬总额为 237.87 万元,在一众高管中薪酬最高,她上任后能否救场? 涉嫌造假?同仁堂回应: 没这个产品 近日,上海市消保委发文称,委托中国水产科学研究院东海水产研究所,对市面上热销的 15 款国内外南极磷虾油产品开展了检测和调查,重点关注磷脂、虾 ...
X @Bloomberg
Bloomberg· 2025-12-15 10:04
Argenx fell the most in seven months after saying it will discontinue late-stage trials for an experimental medicine to treat an autoimmune disease affecting the eyes https://t.co/k2EKHoz0U8 ...
Sanofi stock slumps after two setbacks on multiple-sclerosis drug
MarketWatch· 2025-12-15 09:43
Core Viewpoint - Shares of Sanofi experienced a decline following the announcement that the U.S. regulatory review of its multiple-sclerosis drug will not be completed by the end of the year [1] Group 1: Company Updates - Sanofi's multiple-sclerosis drug is facing delays in the U.S. regulatory review process, which is now expected to extend beyond the end of the year [1] - The company also indicated that a trial for a different form of treatment is ongoing, but specific details were not provided [1]
Johnson & Johnson ordered to pay $40 million to 2 women: What is baby powder cancer case?
MINT· 2025-12-15 09:23
A California jury awarded $40 million to two women on Friday, 12 December, who claimed they developed ovarian cancer after long-term use of Johnson & Johnson’s baby powder.Both California residents testified that they had used J&J's baby powder after bathing for about 40 years. They also stated that their ovarian cancer treatments required major surgeries and many rounds of chemotherapy.The healthcare giant, meanwhile, plans to appeal the jury's decision on both the liability verdict and the compensatory da ...