TG Therapeutics Conference Call Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Event**: Conference Call on November 12, 2025 Key Points Product Performance and Market Position - **Briumvi Launch Success**: Briumvi has established itself as a trusted product among physicians, with many moving it to the first IV slot due to its data and patient convenience [3][5] - **Patient Support Programs**: TG Therapeutics maintains the most generous patient support programs, unlike competitors who have cut back, contributing to its market position [5][6] - **Crossover Patients**: A significant portion of Briumvi's patients are switching from other therapies, with a stable distribution among naive patients, switches from non-CD20 therapies, and switches from other CD20 therapies [9][10] Clinical Trials and Future Expectations - **Enhanced Trial Enrollment**: Impressive enrollment rates in the enhanced trial combining initial doses, with expectations for a successful outcome based on area under the curve measures [12][13] - **Subcutaneous (SubQ) Version**: The company is optimistic about the SubQ version of Briumvi, targeting non-inferiority to IV dosing, with enrollment expected to complete in the first half of next year and data anticipated in late 2026 or early 2027 [29][32] Competitive Landscape - **Ocrevus and BTK Inhibitors**: Current market dynamics show limited impact from Ocrevus SubQ on Briumvi's uptake. The company believes BTK inhibitors will compete more in the oral category rather than against CD20 therapies [17][19][20] - **Market Dynamics for SubQ**: The SubQ version is expected to capture a significant market share, potentially doubling the total addressable market, with a competitive edge in convenience over existing products [33][34] Revenue and Growth Expectations - **Q4 Guidance**: The company is confident in meeting or exceeding Q4 guidance, citing positive dynamics typically seen in the fourth quarter [23][24] - **2026 Growth Initiatives**: Plans to expand direct-to-consumer (DTC) campaigns and enhance field team effectiveness to drive growth in 2026 [26][27] Pipeline and Future Projects - **Exploratory Programs**: The company is cautiously optimistic about ongoing exploratory programs, including MG trials and azer-cel, with potential for clearer direction in 2026 [35][36] Additional Insights - **Patient Awareness**: The DTC campaign has reportedly raised awareness, with patients actively requesting Briumvi after seeing commercials, indicating a positive trend for future sales [26][27] - **Team Performance**: The field team has received positive feedback, and the company is considering adding more personnel to strengthen market presence [27][28] This summary encapsulates the key insights from the TG Therapeutics conference call, highlighting the company's strategic positioning, product performance, competitive landscape, and future growth initiatives.

Core Viewpoint - Shanghai Kaibao (300039.SZ) has received the Clinical Trial Approval Notice from the National Medical Products Administration for its drug KBZ24020, which is intended for clinical trials in treating acute ischemic stroke [1] Company Summary - The clinical trial application for KBZ24020 was accepted on August 25, 2025, and has met the requirements for drug registration [1] - KBZ24020 is derived from clinical experience and is indicated for clearing heat and resolving phlegm, specifically for treating acute ischemic stroke with phlegm-heat syndrome [1] Industry Summary - The drug is aimed at addressing symptoms associated with acute ischemic stroke, including hemiplegia, limb numbness, dizziness, irritability, heavy breath, sticky phlegm in the mouth, yellow tongue coating, and constipation [1]

Core Viewpoint - The announcement highlights the early efficacy of CU-10201, a topical 4% minocycline foam, for treating moderate to severe acne vulgaris, which has been selected for presentation at the 20th CDA Annual Meeting [1] Group 1: Product Information - CU-10201 is the first and only approved topical minocycline for acne treatment globally and has received priority review and approval from the National Medical Products Administration of China [1] - The product has demonstrated efficacy and safety in a 12-week Phase III clinical trial for Chinese patients with moderate to severe acne vulgaris [1] Group 2: Clinical Trial Insights - The post-hoc analysis aims to evaluate the early efficacy of CU-10201 in Chinese patients with moderate to severe facial acne during the first and second weeks of treatment [1] - Efficacy analysis indicates that CU-10201 shows a significant characteristic of rapid onset, with notable improvement in inflammatory lesions observed in the first week and further enhancement by the second week [1] - These early efficacy data suggest that CU-10201 can provide a rapid symptom relief treatment option for acne vulgaris patients, holding important clinical significance [1]

Core Viewpoint - The announcement highlights the early efficacy of CU-10201, a topical 4% minocycline foam, for treating moderate to severe facial acne, which has been selected for oral presentation at the 20th CDA Annual Meeting [1] Group 1: Product Information - CU-10201 is the first and only approved topical minocycline for acne treatment globally and has received priority review approval from the National Medical Products Administration of China [1] - The product has demonstrated efficacy and safety in a 12-week Phase III clinical trial for moderate to severe acne patients in China [1] Group 2: Clinical Trial Insights - The post-hoc analysis aims to evaluate the early efficacy of CU-10201 in patients with moderate to severe facial acne during the first and second weeks of treatment [1] - Efficacy analysis indicates that CU-10201 shows a significant characteristic of rapid onset, with notable improvement in inflammatory lesions observed in the first week and further enhancement by the second week [1] - These early efficacy data suggest that CU-10201 provides a rapid symptom relief treatment option for acne patients, holding important clinical significance [1]

Core Insights - Guangdong Hengrui Medicine Co., Ltd. has initiated a Phase I clinical trial for HRS-9813, a drug aimed at treating pulmonary fibrosis, with the trial registered under CTR20254413 and publicly announced on November 6, 2025 [1] Group 1: Clinical Trial Details - The primary objective of the trial is to evaluate the pharmacokinetic interactions of HRS-9813 capsules with pirfenidone and nintedanib in healthy subjects [1] - Secondary objectives include assessing the safety and tolerability of the drugs when used alone and in combination, as well as exploring the metabolic characteristics of HRS-9813 in healthy subjects [1] - The trial is currently ongoing with a target enrollment of 20 participants, although recruitment has not yet started [2] Group 2: Drug Information - HRS-9813 is a chemical drug indicated for pulmonary fibrosis, a condition characterized by lung tissue damage leading to scarring, with symptoms including dry cough and progressive shortness of breath [1] - High-resolution CT scans can assist in the diagnosis of pulmonary fibrosis [1]

Group 1 - The core viewpoint of the article is that Zhongsheng Pharmaceutical is actively advancing the Phase III clinical trial of its drug, Anglatide granules (research code: ZSP1273) [1] Group 2 - The company has communicated this progress through its investor interaction platform [1]

格隆汇11月3日丨恒瑞医药(600276.SH)公布，公司收到国家药品监督管理局核准签发关于瑞维鲁胺片的 《药物临床试验批准通知书》，将于近期开展临床试验。瑞维鲁胺片是第二代 AR 抑制剂，相较于第一 代 AR 抑制剂，具有更强的AR抑制作用，且无激动作用。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的全部內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） （股份代號：6855） 自願公告 亞盛醫藥耐立克®、利生妥®、APG-5918的多項臨床進展將 在2025年美國血液學會年會(ASH)展示，其中一項獲口頭報告 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司3個品種（耐立克®、利 生妥®、APG-5918）有多項臨床和臨床前進展入選第67屆美國血液學會(American Society of Hematology, ASH)年會展示及報告，其中一項獲口頭報告。其中，本 公司原創1類新藥奧雷巴替尼（商品名：耐立克®）有多項臨床進展獲選第67屆ASH 年會，這是該品種的臨床進展連續第8年入選ASH年會。此外，本公司原創1類新 藥利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）共有2項臨床進展獲選 第67屆ASH年會， ...

普瑞巴林是一种新型钙离子通道调节剂，能有效阻断电压依赖性钙通道，减少神经递质的释放。普瑞巴 林缓释片临床上主要用于治疗糖尿病周围神经病变(DPN)相关的神经病理性疼痛和带状疱疹后神经痛 (PHN)。宜昌人福于2023年首次获得本品的《药物临床试验批准通知书》，首次获批临床的适应症为用 于治疗糖尿病周围神经病变所伴有的神经性疼痛(DPN)。本次申请的普瑞巴林缓释片拟新增适应症为用 于治疗带状疱疹后神经痛(PHN)。 智通财经APP讯，人福医药(600079.SH)发布公告，公司控股子公司宜昌人福药业有限责任公司(简称"宜 昌人福"，公司持有其80%的股权)近日收到国家药品监督管理局核准签发的普瑞巴林缓释片《药物临床 试验批准通知书》。 ...

Core Insights - The webinar discusses a recently published paper in eBioMedicine, part of the Lancet Discovery Group Journals, highlighting the results of a study conducted by Intensity Therapeutics [2] Group 1: Company Overview - Intensity Therapeutics is led by Lewis H. Bender, who serves as the Founder, President, CEO, and Chairman of the Board [2] - The company is focused on clinical trials for its drug INT230-6, with expectations for future performance being a key topic of discussion [3] Group 2: Study Results - The company expressed excitement about the results of the study, indicating a positive outlook for the findings presented in the paper [2]