Group 1 - The core viewpoint of the article highlights that Zai Lab Limited (荃信生物-B) experienced a significant increase in its stock price, rising over 6% following the release of its interim financial results [1] - The company reported a revenue of RMB 206 million, representing a year-on-year increase of 359.69% [1] - The net loss for the period was RMB 30.93 million, which is a reduction of 83.11% compared to the previous year [1] Group 2 - The revenue primarily consisted of income from licensing agreements, including an upfront payment related to the overseas licensing of QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, totaling RMB 181 million [1] - Additional revenue was generated from CDMO services and R&D services for projects QX004N and QX008N, amounting to approximately RMB 22 million [1] - The company announced a placement of 5 million new shares to TruMed Health Innovation Fund LP at a price of HKD 20 per share, raising approximately HKD 99 million, with about 60% allocated for repaying existing interest-bearing bank loans [1][1]

证券研究报告·公司点评报告·医药生物 新诺威（300765） 2025 年中报点评：持续加码研发，EGFR ADC 下半年有望启动首个海外注册临床 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 2,539 | 1,981 | 2,392 | 2,765 | 3,294 | | 同比（%） | (3.34) | (21.98) | 20.76 | 15.59 | 19.13 | | 归母净利润（百万元） | 434.44 | 53.73 | 57.30 | 58.91 | 128.17 | | 同比（%） | (40.18) | (87.63) | 6.66 | 2.80 | 117.57 | | EPS-最新摊薄（元/股） | 0.31 | 0.04 | 0.04 | 0.04 | 0.09 | | P/E（现价&最新摊薄） | 171.36 | 1,385.60 | 1,299.09 | 1,263.68 | ...

来源：新浪港股-好仓工作室 主营业务与商业模式 华芢生物成立于2012年，作为一家总部位于中国的生物制药公司，专注于开发针对有医疗需求及市场机 会适应症的蛋白质药物，主攻方向为伤口愈合疗法，目前聚焦于血小板衍生生长因子（PDGF）药物。 公司商业模式围绕PDGF药物的研发、临床试验及未来商业化展开。截至最后实际可行日期，其管线包 含两款核心产品，即用于治疗烧烫伤的Pro - 101 - 1及用于治疗糖尿病足溃疡（"糖足"）的Pro - 101 - 2， 以及八款其他候选产品。 研发管线进展 候选产品治疗靶点适应症剂型临床试验地区开发阶段预计完成时间主管机构商业权益研发方式Pro - 101 - 1烧烫伤外用凝胶中国已完成IIb期临床试验，处于确定临床试验报告阶段预计2025年第四季度完成II期 国家药监局全球自主研发美国预计2026年第一季度提交IND申请FDA全球Pro - 101 - 2糖足外用凝胶中国 正在进行II期临床试验预计2027年第二季度完成II期，并于2027年第三季度启动III期国家药监局全球与 军科院生物工程研究所联合研发Pro - 101 - 3新鲜创面外用凝胶中国预计2025年第四季度 ...

格隆汇8月13日丨亿胜生物科技(01061.HK)公布，用以治疗湿性AMD的anti-VEGF眼用注射生物药品 （HLX04-O）的生物制品许可申请已于近期获得中国国家药品监督管理局（NMPA）药品审评中心 （CDE）受理。 截至本公布日期，据董事所深知，中国尚无获批准的用于治疗湿性AMD的贝伐珠单抗产品。根据 IQVIA CHPA的最新数据，于中国上市的针对湿性AMD适应症的药物的2024年销售额约为人民币49亿 元。 HLX04-O是在复宏汉霖自主研发的汉贝泰（贝伐珠单抗注射液）的基础上，根据眼科用药的需求对汉 贝泰（贝伐珠单抗注射液）的处方、规格和生产工艺进行优化，在活性成份不变的基础上，开发的新的 眼科制剂产品，拟用于湿性AMD的治疗。 ...

Core Viewpoint - Hunan Maijizhi Biotechnology Co., Ltd. (referred to as "Maijizhi") has submitted an application for listing on the Hong Kong Stock Exchange, with CICC as the exclusive sponsor. The company has been experiencing continuous losses but has seen its post-investment valuation increase nearly 45 times over the past eight years [1][2][9]. Company Overview - Established in 2016, Maijizhi is a clinical-stage biopharmaceutical company focused on addressing unmet medical needs in allergic diseases, autoimmune diseases, and other inflammatory and immune diseases. The company currently has no products on the market, with its core product MG-K10 being a long-acting anti-IL-4Rα antibody with "best-in-class" potential [5][6]. Product Pipeline - MG-K10 targets atopic dermatitis (AD), a chronic inflammatory skin disease with a significant global burden, affecting at least 230 million people. In China, the prevalence of AD has increased by 25.65% from 1990 to 2019, with approximately 36.09 million patients currently, including about 9.63 million with moderate to severe cases [5][6]. - In addition to MG-K10, Maijizhi has two other self-developed products in clinical stages: MG-014, targeting asthma and COPD, and MG-013, an anti-MASP-2 monoclonal antibody aimed at rare and inflammatory diseases [6][7]. Financial Performance - For the first three months of 2023, 2024, and 2025, Maijizhi reported revenues of 8.72 million, 24,000, and 0, respectively, with corresponding net losses of 253 million, 178 million, and 27.3 million. The company incurred significant R&D expenses of 166 million and 150 million in 2023 and 2024, leading to a total adjusted net loss of approximately 307 million over these two years [7][8]. - In Q1 2025, the company recorded no revenue and continued to incur losses with R&D expenses of 24.3 million [8]. Valuation Growth - The company's valuation has seen substantial growth over the years, starting from 58 million in early 2017 to 2.64 billion in May 2025, reflecting a nearly 45-fold increase [9][10]. IPO Fund Utilization - The funds raised from the IPO will be used for ongoing and planned clinical trials of the core product MG-K10, as well as for MG-014 and MG-013, along with other preclinical and discovery-stage assets [11].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for nine companies, including Hemei Pharmaceutical, which is seeking to list on the Hong Kong Stock Exchange. The CSRC is requesting detailed explanations regarding the company's previous A-share listing guidance and its future plans for A-share listing [1][2]. Group 1 - The CSRC has requested Hemei Pharmaceutical to clarify its previous A-share listing guidance and whether it plans to continue with the A-share listing, including any significant impacts on the current listing process [1][2]. - Hemei Pharmaceutical was established in 2002 and is an innovative biopharmaceutical company focused on discovering and developing small molecule drugs for autoimmune diseases and tumors, maintaining a leading position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [2]. - As of May 21, 2025, Hemei Pharmaceutical has developed seven small molecule drug candidates targeting high unmet needs in autoimmune and tumor diseases, with four candidates in Phase II, III clinical trials, or NDA stages for twelve indications [2]. Group 2 - Hemei Pharmaceutical's core product, Mufemilast, is a novel small molecule phosphodiesterase 4B (PDE4B) protein expression blocker and PDE4 inhibitor, showing potential for treating a wide range of autoimmune diseases. According to Frost & Sullivan, Mufemilast may be a first-in-class drug with dual mechanisms of action [2].

Group 1 - The company expects a net loss attributable to shareholders of the parent company for the first half of 2025 to be between -110 million and -140 million yuan, representing a reduction in loss of 96.84 million to 126.84 million yuan compared to the same period last year [2] - The expected net loss attributable to shareholders after deducting non-recurring gains and losses is projected to be between -160 million and -190 million yuan, indicating a reduction in loss of 80.33 million to 110.33 million yuan [2] - The previous year's net loss attributable to shareholders was -236.85 million yuan, with a net loss after deducting non-recurring gains and losses of -270.33 million yuan [4] Group 2 - The company anticipates a decrease in losses due to increased market expansion, with sales of Adalimumab injection (Geleli) expected to rise, contributing an additional revenue of 20 million to 50 million yuan compared to the previous year [6] - Research and development expenses are expected to decrease by 40 million to 70 million yuan compared to the previous year, primarily because several R&D projects have completed Phase III clinical trials, with BAT2206, BAT2306, and BAT2506 currently in the application stage for market approval [6] - BAT2206 has already received FDA approval for market launch in the United States, which has contributed to the reduction in R&D expenses [6]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed drug "B019" for the treatment of refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, aimed at treating refractory systemic lupus erythematosus [1] - The project has accumulated research and development expenses of approximately 149,000 RMB for this new indication [1]

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，概不對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。 自願公告 重組抗人 IL-17A/F 人源化單克隆抗體注射液Ⅲ期臨床試驗 達到主要研究終點 近日，麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*（「本公司」）控股附 屬公司珠海市麗珠單抗生物技術有限公司（「麗珠單抗」）與北京鑫康合生物醫藥科技 有限公司聯合開發的"重組抗人IL-17A/F人源化單克隆抗體注射液"（「LZM012」或「本 品」）的Ⅲ期臨床試驗達到主要研究終點。現將有關詳情公告如下： 一、藥品基本情況 藥品名稱：重組抗人IL-17A/F人源化單克隆抗體注射液 英文名/拉丁名：Recombinant anti-human IL-17A/F Humanized Monoclonal Antibody Injection 劑型：注射劑 註冊分類：治療用生物製品1類 規格：160 mg（1.6mL）/瓶 上市申請人：珠海市麗珠單抗生物技術有限公司 本公司 ...

Core Viewpoint - Hunan Maijizhi Biotechnology Co., Ltd. (referred to as "Maijizhi") has officially submitted its IPO application to the Hong Kong Stock Exchange, marking a significant step in its growth as a biopharmaceutical company focused on innovative biologics for inflammatory and immune diseases [3][9]. Company Overview - Established in 2016, Maijizhi has developed a pipeline of eight innovative candidate products, including core product MG-K10 and key products MG-014 and MG-013, with three candidates already in clinical stages [5][7]. - MG-K10 is a long-acting anti-IL-4Rα antibody designed for the precise treatment of moderate to severe atopic dermatitis and asthma, with a half-life 2 to 3.5 times longer than similar antibodies on the market [5][7]. Clinical Development - MG-K10 has made significant progress in clinical research, having completed Phase II trials for atopic dermatitis and currently undergoing Phase III trials for atopic dermatitis, asthma, nodular prurigo, and Phase II/III trials for seasonal allergic rhinitis in China [7][8]. - The company has established a comprehensive clinical development plan, with key milestones including the submission of a Biologics License Application (BLA) expected in the second half of 2025 [8]. Financial and Investment Highlights - Maijizhi has secured a total investment of 1.5 billion yuan from Xiangjiang Guotou, holding a 6.59% stake in the company, which has facilitated its clinical research progress [9]. - The company completed a Pre-IPO financing round in July, raising 260 million yuan, resulting in a post-investment valuation of 2.64 billion yuan [8].