Core Viewpoint - BeiGene has achieved its first quarterly profit under GAAP, with a net profit of $1.27 million, driven by rapid global revenue growth and effective management of operating expenses [1] Financial Performance - In Q1 2025, BeiGene reported a revenue of 8.048 billion yuan, a year-on-year increase of 50.2%, with product revenue reaching 7.985 billion yuan, up 49.9% [1] - The company transitioned from losses to profits, achieving an operating profit and total profit of approximately 150 million yuan [1] - The company maintains its 2025 financial guidance, expecting annual revenue between 35.2 billion yuan and 38.1 billion yuan, with positive operating profit and cash flow from operations [2] Product Performance - The BTK inhibitor, Brukinsa (Zebutinib), generated sales of 5.692 billion yuan in Q1 2025, a 63.7% increase year-on-year, and ranked 20th globally in oncology drug sales with projected sales of $2.6 billion in 2024 [2] - In the U.S. market, Brukinsa's sales reached 4.041 billion yuan in Q1 2025, reflecting a 61.9% year-on-year growth, and it became the market leader in the BTK inhibitor segment [2] - The PD-1 monoclonal antibody, Tislelizumab (BGB-A317), achieved sales of 1.245 billion yuan, a 19.3% increase, driven by new patient demand from recently approved indications included in the national medical insurance catalog [2] Market Dynamics - The global BTK inhibitor market has six approved products, with BeiGene's Brukinsa being a second-generation BTK inhibitor that has shown continuous sales growth due to its efficacy over first-generation inhibitors [3] - The competitive landscape includes Eli Lilly's Jaypirca (Pirtobrutinib), the only third-generation BTK inhibitor, which addresses resistance issues through a unique mechanism [4] Research and Development - BeiGene is developing a new BTK degrader, BGB-16673, which has shown therapeutic advantages in patients with prior BTK treatment, and is expected to enter Phase 3 clinical trials comparing it to non-covalent BTK inhibitors [5]

康方生物新药依沃西新适应症获批上市，然而，康方生物的美国合作方SMMT公司周五股价暴跌超过36%，原因何在?这对康方生物影响几何? 01 长按即可参与 断崖式暴跌 SMMT重挫36% 国家药品监督管理局官网显示，康方生物全球首创双特异性抗体新药依沃西新适应症获批上市，单药用于PD-L1表达阳性的局部晚期或转移性非小 细胞肺癌（NSCLC）的一线治疗。 尽管 PFS 数据亮眼， OS（总生存期） 的未达预期却引发了资本市场的剧烈波动。分析认为，投资者的失望源于两点： 消息面上，在周五宣布 依沃西 获中国批准用于一线 PD-L1 阳性非小细胞肺癌（ NSCLC ）时，康方生物披露了备受关注的 HARMONi-2 试验中 期分析结果：与 Keytruda（简称K药， 全球最畅销抗癌药物 ） 相比，依沃西 将死亡风险降低了 22.3% （风险比 HR=0.777 ）。 然而，这一数据未能跨越预先设定的统计学显著性门槛（ α=0.0001 ）。该分析基于 39% 预设死亡事件时的数据得出。 值得注意的是，中国监管部门批准 依沃西 的依据是其无进展生存期（ PFS ）数据：与K药 相比，依沃西 使疾病进展或死亡风险降低了 ...

Core Viewpoint - The recent incident involving the articles published by "Meisi Oncology New Frontier" highlights the intensifying competition in the PD-1 monoclonal antibody market, indicating a shift towards a saturated market where established players dominate future growth opportunities [4][5][8]. Market Dynamics - The PD-1 monoclonal antibody market has transitioned from a "golden track" to a "red ocean" due to increased product launches leading to homogenization of competition [5][8]. - Major players like Merck's "K drug" (pembrolizumab) and Bristol-Myers Squibb's "O drug" (nivolumab) continue to show strong sales, with projected global revenues of approximately $29.5 billion and $10.1 billion respectively for 2024 [5][6]. - In China, BeiGene's tislelizumab leads with sales of 4.467 billion yuan, a 17.4% increase year-on-year, while Innovent's sintilimab and Junshi Biosciences' toripalimab also report significant growth [6][7]. Competitive Landscape - The market is characterized by a clear division between leading companies with established products and newer entrants struggling to gain market share [8][9]. - Companies that fail to differentiate their products or adapt to the competitive landscape are increasingly exiting the PD-1 market, with at least six companies having withdrawn in the past four years [9][12]. Future Trends - The emergence of PD-1 bispecific antibodies is seen as a potential game-changer, with products like Ivosidenib showing superior efficacy in clinical trials compared to traditional PD-1 monoclonal antibodies [14][15]. - The potential for PD-1 bispecifics to address "hard-to-treat" patient populations and improve outcomes in various cancer types is being recognized as a significant opportunity for innovation [16]. Broader Applications - Beyond oncology, PD-1 inhibitors are being explored for autoimmune diseases, with ongoing clinical trials for conditions like rheumatoid arthritis [19][20]. - The distinction between PD-1 inhibitors and PD-1 agonists is crucial, as the latter has not yet seen any products approved for market, indicating a potential area for future development [20].

Group 1 - The stock of Sanofi (三生国健688336) has a comprehensive score of 60.82, indicating a strong performance [1] - The main cost analysis shows the current price at 29.23 CNY, with a 5-day cost of 27.83 CNY and a 20-day cost of 24.28 CNY [1][3] - There have been no instances of the stock hitting the upper or lower limits in the past year [1] Group 2 - The short-term resistance level is at 28.04 CNY, while the short-term support level is at 26.95 CNY [2] - The stock price has broken through the short-term resistance level, suggesting a potential short-term strength [2][3] - The K-line pattern indicates a "Red Three Soldiers" formation, suggesting a possible bottoming out and recovery [2][3] Group 3 - On April 1, 2025, the net inflow of main funds was 14.66 million CNY, accounting for 7% of the total transaction volume [2] - Large orders saw a net inflow of 18.18 million CNY, while super large orders experienced a net outflow of 3.52 million CNY [2][3] - Retail investors contributed a net inflow of 502,100 CNY [2] Group 4 - The latest financial data shows earnings per share at 0.38 CNY, with an operating profit of 262 million CNY [2] - The gross profit margin stands at 71.259%, with a net profit of 222.76 million CNY [2][3] - The stock is associated with sectors such as bioproducts (4.38%), monoclonal antibodies (4.73%), and recombinant proteins (5.50%) [2]

Group 1 - The stock of Zejing Pharmaceutical (U688266) has a comprehensive score of 73.92, indicating a strong performance [1] - The main cost analysis shows that the current main cost is 106.70 yuan, with a 5-day cost of 98.01 yuan, a 20-day cost of 92.27 yuan, and a 60-day cost of 75.63 yuan [1] - There have been no instances of the stock hitting the upper or lower limits in the past year [1] Group 2 - The technical analysis indicates a short-term resistance level at 99.74 yuan and a support level at 86.68 yuan, while the mid-term resistance is also at 99.74 yuan with a support level at 85.63 yuan [2] - The stock price has broken through the short-term resistance level, suggesting potential strength in the short term, and a break through the mid-term resistance could indicate strength in the medium term [2] - The K-line pattern shows a "Red Three Soldiers" formation, indicating a possible bottoming and rebound [2] Group 3 - On April 1, 2025, the net inflow of main funds was 84.50 million yuan, accounting for 15% of the total transaction volume [2] - The net inflow from large orders was 36.91 million yuan, while the net inflow from super large orders was 47.59 million yuan [2] - The stock is associated with sectors such as chemical pharmaceuticals (4.36%), monoclonal antibodies (4.73%), and immunotherapy (4.14%) [2]

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...

有望为国内银屑病患者提供更可负担的用药选择。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，11月5日，华东医药（000963.SZ）发布公告，其下属杭州中美华东制药有限公 司（下称"中美华东"）收到国家药监局（NMPA）核准签发的《药品注册证书》，由中美华东与荃 信生物（2509.HK）联合开发的乌司奴单抗注射液赛乐信（研发代码：HDM3001/QX001S）的上 市许可申请获得批准，用于治疗成年中重度斑块状银屑病，成为国内首个乌司奴单抗注射液生物类似 药。 赛乐信是原研产品Stelara（喜达诺，乌司奴单抗注射液）的生物类似药，为一款白介素IL-12/23 单抗药物。据强生公司2023年报，2023年Stelara在全球的销售额为108.58亿美元（约767.29亿 元人民币）。米内网数据显示，2023年喜达诺在中国的销售额为13.22亿元人民币。 此次赛乐信获批上市，有望为国内银屑病患者带来更可负担的用药选择。 本文由公众号IPO早知道（ID：ipozaozhidao）原创撰写，如需转载请联系C叔↓↓↓ QX001S最初由荃信生物自主研发，2020年8月， ...