帕妥珠单抗注射液POHERDY
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异动盘点1120 |茂盛控股涨超14%,猫眼娱乐再跌超2%;美股光通信板块全线走高,网易跌4.15%
贝塔投资智库· 2025-11-20 04:01
Group 1 - Maosheng Holdings (00022) saw a rise of over 14% due to a 75.4% year-on-year increase in revenue for the six months ending September 30, 2025, attributed to the final stages of renovation construction services [1] - Emperor Capital (00717) increased by over 3.8% as net profit rose significantly due to a large reduction in impairment provisions for margin loans and other loans, alongside an increase in group revenue [1] - Ginkgo BioWorks-B (01167) rose over 5.4% following the approval of its self-developed KRAS G12C inhibitor, Goresir, for commercialization in China, with a partnership established with Ailida [1] - Maoyan Entertainment (01896) fell over 2% as reports indicated an increase in the ticket refund rate for "Demon Slayer" [1] - Fuhong Hanlin (02696) increased by over 4.3% after announcing FDA approval for its biosimilar to PERJETA, making it the first and only biosimilar of its kind in the U.S. [1] Group 2 - Trip.com Group-S (09961) dropped over 3.4% despite reporting a net operating revenue of 18.3 billion RMB for Q3 2025, a 16% year-on-year increase driven by sustained global travel demand [2] - Gushengtang (02273) rose over 2.2% after announcing a share transfer agreement with DA ZHONG TANG PTE. LTD. [2] - XPeng Motors-W (09868) fell over 4.6% amid market speculation about plans to produce thousands of autonomous taxis annually from 2026-2027 [2] - Techtronic Industries (00669) increased by over 4.7% as Home Depot's Q3 results indicated a positive outlook for the U.S. consumer market, benefiting Techtronic's professional segment [2] Group 3 - Guofu Quantum (00290) rose over 2.8% as it projected a net profit of approximately 200 million to 210 million HKD for the six months ending September 30, compared to a net loss of about 10.9 million HKD in the same period last year [3] Group 4 - Circle (CRCL.US) fell 8.98% as its stock price continued to decline since late October, with a significant insider sale reported [4] - The U.S. optical communication sector saw gains, with Lumentum (LITE.US) up 8.69% and other companies in the sector also rising [4] - Storage stocks in the U.S. rose, with Seagate Technology (STX.US) up 2.08% following a report on NVIDIA's shift to low-power memory chips for AI servers [5] - MP Materials (MP.US) increased by 8.61% after announcing a joint venture with the U.S. Department of Defense and Saudi Arabia's Maaden to build a rare earth refining plant [5] - Google (GOOGL.US) rose 3% as its new AI model Gemini 3 Pro topped the LMArena leaderboard, highlighting AI's role in its growth [6] - Nokia (NOK.US) fell over 9.19% as it focuses on AI-related infrastructure [6] - Block (XYZ.US) rose 7.56% after announcing a $5 billion increase in its stock buyback plan [6] - NetEase (NTES.US) fell 4.15% following the global launch of its new game [6] - Lowe's (LOW.US) rose 4.03% after reporting Q3 revenue of $20.81 billion, slightly below market expectations [6]
复宏汉霖现涨超4% POHERDY在美获批上市 可覆盖原研产品所有适应症
Zhi Tong Cai Jing· 2025-11-20 03:05
Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Group 1: Company Developments - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved the biosimilar injection of pertuzumab, POHERDY, which can be used interchangeably with the original product PERJETA, covering all indications approved for the original product in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] Group 2: Market Position - Fuhong Hanlin has submitted marketing applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those products receiving approval in the U.S. [1]
复宏汉霖逆市涨超3% 帕妥珠单抗生物类似药POHERDY获美国FDA批准
Zhi Tong Cai Jing· 2025-11-18 01:52
Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, with a transaction volume of 3.9331 million HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA [1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, making it the first and only biosimilar of PERJETA in the U.S. market, covering all indications approved for PERJETA [1] - The approval is expected to enhance Fuhong Hanlin's market position and potentially increase revenue streams from the U.S. market [1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulizumab injection (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, marking its first potential recognition [1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally, indicating significant advancements in Fuhong Hanlin's product pipeline [1]
港股异动 | 复宏汉霖(02696)逆市涨超3% 帕妥珠单抗生物类似药POHERDY获美国FDA批准
智通财经网· 2025-11-18 01:51
Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA, making it the first and only biosimilar of PERJETA in the U.S. market [1][1][1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, allowing it to be used interchangeably with the original product PERJETA [1][1] - POHERDY is now the first and only biosimilar of PERJETA approved in the U.S., covering all indications for which PERJETA has been approved [1][1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulitin (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1][1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally [1][1]
国家药监局:畅通新功效化妆品注册渠道;6连板人民同泰:当前股价涨幅与业绩严重偏离丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-11-17 23:15
Group 1: Regulatory Changes in Cosmetics Industry - The National Medical Products Administration (NMPA) has released opinions to streamline the registration process for new functional cosmetics, implementing an immediate review system [1] - The new measures encourage international cosmetic products to debut in China without needing overseas sales proof and support product development targeting the elderly [1] - The aim is to address bottlenecks in the cosmetics industry and inject new vitality for high-quality development [1] Group 2: Clinical Approvals in Pharmaceuticals - Heng Rui Medicine announced that its HRS-6209 capsules and HRS-2189 tablets have received clinical trial approval from the NMPA, indicating strong R&D capabilities in innovative drugs [2] - The recent approvals of multiple anti-cancer drugs are expected to boost the company's stock price in the short term [2] Group 3: Strategic Investments in Pharmaceutical Sector - Nanjing Medicine has received approval for Guangzhou Pharmaceutical Group's second-phase fund to acquire 11.04% of its shares, valued at RMB 749 million [3] - This strategic cooperation between Baiyunshan, Nanjing Medicine, and the fund is expected to enhance business collaboration and optimize regional industrial layout [3] Group 4: Stock Performance and Market Sentiment - Renmin Tongtai has reported that its stock price has significantly deviated from its operational performance, indicating potential risks of market overreaction and irrational speculation [4] - The company warns investors to be cautious of the stock's volatility and high valuation risks due to the current market sentiment [4] Group 5: International Market Approvals - Fuhong Hanlin announced that its self-developed biosimilar of Pertuzumab has been approved by the FDA, becoming the first and only biosimilar of its kind in the U.S. market [5] - This approval signifies recognition of the company's products in the international market and is expected to enhance its global influence [5]
复宏汉霖帕妥珠单抗生物类似药POHERDY获美国FDA批准
Bei Jing Shang Bao· 2025-11-17 13:06
Core Insights - The biopharmaceutical license application (BLA) for Pertuzumab injection (420mg/14mL) POHERDY has been approved by the U.S. Food and Drug Administration (FDA), making it the first and only biosimilar to PERJETA (pertuzumab) in the U.S. market [1][1][1] - This approval allows for interchangeability with the original product PERJETA and covers all indications for which PERJETA has been approved in the U.S. [1][1][1] - The approval represents a significant milestone in improving access to high-quality and potentially more affordable treatment options for patients with specific HER2-positive breast cancer [1][1][1]