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我国研究团队发表成果,慢性鼻窦炎伴鼻息肉治疗取得新突破
Xin Jing Bao· 2025-08-23 06:21
该病难治的原因在于患者多伴随全身系统性2型炎症,导致鼻窦炎症状持续存在。司普奇拜单抗是我国 自主研发的首个IL-4Rα靶向单抗药物,具有抗2型炎症作用。张罗教授团队在前期的II期临床试验 CROWNS-1研究中已证实,司普奇拜单抗在难治性慢性鼻窦炎伴鼻息肉治疗中具有良好的安全性和耐 受性。本项研究(CROWNS-2)为全国多中心、随机、双盲、安慰剂对照Ⅲ期临床试验,旨在评估司普奇 拜单抗在大样本慢性鼻窦炎伴鼻息肉人群中的疗效和安全性。 2022年8月至2023年4月期间,CROWNS-2研究共招募来自全国51个中心的180例症状严重且经规范药物/ 手术治疗未控制的慢性鼻窦炎伴鼻息肉患者,通过1:1随机分组,分别给予司普奇拜单抗或安慰剂治 疗。研究人群包括嗜酸性粒细胞型和非嗜酸性粒细胞型慢性鼻窦炎伴鼻息肉患者,是国际上首个采用组 织病理学指标(息肉组织嗜酸性粒细胞计数≥55个/高倍镜视野或百分比≥27%)作为入组和分层随机化标准 的Ⅲ期临床研究。 新京报讯(记者戴轩)慢性鼻窦炎伴鼻息肉是常见的上呼吸道慢性炎症性疾病,我国患者超4000万,在现 有治疗体系下,一半以上患者不能有效控制症状。我国团队近期发布研究成果 ...
注射剂可网上购买、冷链运到家?生物制剂切勿网购
Nan Fang Du Shi Bao· 2025-07-10 15:12
Core Viewpoint - The article discusses the rise of monoclonal antibody (mAb) injections, also known as "biological agents," in the treatment of chronic diseases, highlighting the issues surrounding their online sale and the importance of proper medical supervision for their use [1][11]. Group 1: Market Trends - Monoclonal antibodies are becoming mainstream treatments for chronic diseases such as autoimmune disorders and skin diseases due to the expansion of indications and domestic production [1][11]. - The demand for effective treatments in rheumatology and dermatology is increasing, with mAbs being recognized for their significant therapeutic effects [11][12]. Group 2: Online Sales and Regulations - Some pharmaceutical e-commerce platforms are attempting to sell injectable mAbs online, despite regulations prohibiting the online retail of such prescription drugs [2][6]. - Many sellers use terms like "appointment for medication" and "contact customer service after payment" to imply that they are not directly selling the drugs online, which raises compliance concerns [3][6]. Group 3: Safety and Usage - The use of biological agents requires strict adherence to indications and contraindications, necessitating a doctor's assessment and prescription before use [1][5][8]. - Proper cold chain logistics are essential for the safe transport of these drugs, but safety also depends on medical supervision and monitoring during treatment [8][10]. Group 4: Efficacy and Limitations - Biological agents have shown remarkable efficacy in treating various autoimmune diseases, but they are not a cure and require ongoing management [12][13]. - The high cost of mAbs, often thousands of yuan per injection, poses a barrier to access, and their effectiveness can vary among patients [13].
康诺亚-B(02162.HK)拟通过配售及认购总筹8.64亿港元,资金重点投向研发及商业化
Ge Long Hui· 2025-06-11 00:24
Core Viewpoint - 康诺亚-B (02162.HK) has entered into a placement and subscription agreement to sell and issue shares, aiming to raise approximately HKD 864 million for various purposes [1][2]. Group 1: Share Placement and Subscription - The total number of shares to be placed is 21.6 million, representing about 7.72% of the company's issued shares as of the announcement date [2]. - The subscription involves 19 million new shares, accounting for approximately 6.36% of the enlarged share capital post-placement and subscription [2]. - Following the completion of the placement and subscription, the selling shareholder's stake will decrease from about 27.79% to approximately 25.16% of the enlarged issued share capital [2]. Group 2: Pricing and Financial Details - The placement price is set at HKD 45.48 per share, which is a discount of approximately 6.52% compared to the closing price of HKD 48.65 on June 10 [2]. - The total expected proceeds from the subscription are approximately HKD 864 million, with net proceeds estimated at around HKD 854 million [2]. Group 3: Use of Proceeds - The net proceeds are planned to be allocated as follows: approximately 35% for R&D expenses related to CM512, CM518D1, and other pipelines; about 30% for the commercialization of the drug Siplizumab; around 25% for capital expenditures on manufacturing and R&D facilities; and 10% for general corporate and operational purposes [2].
康诺亚-B(02162)、Moonshot Holdings Limited与牵头账簿管理人及联席账簿管理人订立配售及认购协议
智通财经网· 2025-06-11 00:17
Core Viewpoint - 康诺亚-B (02162) has entered into a placement and subscription agreement to sell and issue shares, aiming to raise approximately HKD 854 million for various development and operational purposes [1][2]. Group 1: Share Placement and Subscription - The total number of shares to be placed is 21.6 million, representing approximately 7.72% of the company's issued shares as of the announcement date [2]. - The number of subscription shares is 19 million, accounting for about 6.36% of the expanded share capital post-placement and subscription [2]. - The placement price is set at HKD 45.48 per share, which is a discount of approximately 6.52% compared to the closing price of HKD 48.65 on June 10, 2025 [2]. Group 2: Use of Proceeds - The net proceeds from the subscription, estimated to be around HKD 854 million after deducting commissions and estimated expenses, will be allocated for: - Research and development expenses for CM512, CM518D1, and other pipeline projects [2]. - Commercialization of the drug Siplizumab [2]. - Capital expenditures for manufacturing and research facilities [2]. - General corporate and operational funding [2].
IL-4Rα靶点的“中国答案”:重塑治疗格局,引领鼻科治疗进入生物制剂新时代
Core Insights - The article discusses the challenges faced by patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR), highlighting the limitations of traditional treatments and the emergence of innovative therapies like Dupilumab [1][2][3] Group 1: Patient Challenges - Many patients with CRSwNP and SAR experience inadequate treatment outcomes, with about 50% of CRSwNP patients facing recurrence of symptoms despite standardized medical and surgical interventions [1] - A significant percentage of patients with moderate to severe SAR do not achieve effective symptom control even when using potent nasal corticosteroids and antihistamines [1][3] Group 2: Innovative Treatment Development - The approval of Supilumab (康悦达) by the National Medical Products Administration (NMPA) for CRSwNP in December 2024 marks a significant advancement in treatment options [2] - Supilumab is the first IL-4Rα biological agent approved for SAR, expanding its therapeutic applications [2][3] Group 3: Clinical Efficacy - In clinical trials, Supilumab demonstrated significant efficacy, with 72% of patients showing notable reduction in nasal polyps within two weeks of treatment, and 81% achieving at least a 50% reduction by 24 weeks [3][4] - For SAR, 52% of patients achieved nasal airflow within four days of treatment, and 84% reported mild or no nasal symptoms after four weeks [4] Group 4: Market Potential - The global market for IL-4Rα-targeted drugs is projected to grow significantly, with estimates reaching $12.2 billion by 2024 and $28.7 billion by 2030, reflecting a compound annual growth rate of 15.2% [5] - The competitive landscape is evolving, with domestic companies like 康诺亚 gaining traction in the IL-4Rα drug market, challenging established players [5][6] Group 5: Future Directions - 康诺亚 is actively exploring additional indications for Supilumab, including adolescent atopic dermatitis and nodular prurigo, aiming to address unmet clinical needs and reduce treatment costs [9][11] - The company is also developing a diverse pipeline of therapies, including second-generation bispecific antibodies and ADCs, to enhance treatment options for various diseases [10][11]
成都召开全市对外开放发展大会,提出——由“变量”触发“增量”高水平建设西部对外交往中心
Si Chuan Ri Bao· 2025-04-16 07:05
Group 1: International Connectivity and Trade - Chengdu has 73 international and regional direct flight routes, the highest in the Midwest region [1] - In 2024, Chengdu's international aviation hub is expected to handle 589,000 flights, with passenger throughput exceeding 87 million and cargo volume surpassing 1 million tons [1] - Chengdu's import and export value reached 839 billion yuan in 2024, accounting for 80.2% of the province's foreign trade, with a growth rate of 12.1% [2] Group 2: Economic Development and Investment - Chengdu has attracted 315 Fortune Global 500 companies to establish operations in the city [1][3] - In the first quarter of this year, Chengdu introduced 331 major projects with a total investment of 295.9 billion yuan, achieving 255% and 153% of the planned progress respectively [2] - The city aims to achieve over 5 billion USD in foreign investment, marking a 50% year-on-year increase [2] Group 3: Cultural and Sports Events - Chengdu will host 89 international and domestic events this year, including 45 international competitions [2] - The city is recognized as a popular destination for foreign tourists, expecting to receive 1.65 million inbound visitors in 2024 [1] Group 4: Strategic Initiatives for Open Economy - Chengdu's strategy for high-level opening includes enhancing connectivity, promoting cultural exchange, and improving the international business environment [4][7] - The city plans to open new international routes and enhance the "China-Europe Railway Express" to facilitate trade [7][8] - Chengdu's trade with ASEAN, the US, and the EU has seen significant growth, with increases of 26.9%, 34.7%, and 12.9% respectively [6] Group 5: Corporate Participation and Global Integration - Chengdu encourages local enterprises to participate in international markets, with companies like Connoa Bio and Airbus expressing strong commitment to global integration [9][10] - The city aims to attract cold chain manufacturers from Belt and Road countries to establish operations in Chengdu [10] - The presence of global companies like Linde Group highlights Chengdu's attractiveness for investment and development [10]
陆家嘴财经早餐2025年4月6日星期日
Wind万得· 2025-04-05 23:04
Key Points on Trade and Economic Policies - The Chinese government strongly opposes the U.S. imposition of tariffs, viewing it as a violation of World Trade Organization rules and a threat to global economic stability [3] - Six Chinese trade associations have issued statements against the U.S. tariffs, supporting the government's countermeasures [3] - Following the announcement of the "disastrous" tariff policy, U.S. Treasury Secretary Bessent may be planning to resign due to his opposition to aggressive tariff increases [3] Key Points on Commodity Markets - The commodity market is experiencing significant downturns due to the U.S. government's tariff policies, with oil prices dropping over 8% and gold prices also declining [5] - The unexpected tariff policies have led to increased trade costs for non-U.S. countries, resulting in weakened global economic expectations and reduced commodity demand [5] Key Points on Macroeconomic Indicators - China's commodity price index for March was reported at 113.4 points, showing a month-on-month increase of 0.7% and a year-on-year increase of 1.3%, indicating a positive start to the year [7] - In the first quarter, China's offline consumption index grew by 14.2% year-on-year, with small commodity market activity increasing by 16.3% [8] Key Points on Domestic Stock Market - Gold-related ETFs have seen a surge in investment, with total assets exceeding 110.468 billion yuan and an average net asset growth rate of around 20% this year [10] - Several lithium companies reported significant losses for 2024, with Tianqi Lithium losing 7.905 billion yuan and Ganfeng Lithium losing 2.074 billion yuan, indicating ongoing challenges in the lithium market [10] - Over half of the listed securities firms have reported a reduction in IT personnel, with some major firms cutting over 200 positions, while others are increasing hiring [11] Key Points on Financial Sector Developments - Several small public fund companies have increased their registered capital, reflecting shareholder confidence in the long-term value of the industry [14] Key Points on Real Estate Market - In the first quarter, over 70% of the top 100 real estate companies saw a decline in market value, although there are signs of stabilization in the housing market [16] Key Points on Industry Developments - The State Grid Corporation reported a 27.7% year-on-year increase in investment by the end of March, marking a historical high for the first quarter [18] - The AI open-source community Hugging Face has ranked Alibaba's Qwen2.5-Omni model at the top, indicating advancements in AI technology [18] - The brain-computer interface technology is making significant progress in the medical field, with clinical validation of the "North Brain No. 1" system underway [18] Key Points on International Trade and Tariffs - The U.S. government has officially implemented a 10% baseline tariff on most imported goods [22] - The new tariffs, particularly a 25% tariff on imported cars, have raised concerns in Germany, which heavily relies on exports to the U.S. [22] - The new tariff policies are expected to increase costs for various industries in the U.S., ultimately affecting consumers [22] Key Points on International Stock Market Reactions - Nintendo has postponed the pre-order of its Switch 2 in the U.S. due to the potential impact of the new tariffs [26] - Jaguar Land Rover has suspended exports to the U.S. in response to the new tariff measures [26] Key Points on Commodity Prices - Global trade tensions have led to a sell-off in gold, with prices adjusting downwards despite a year-to-date increase of over 15% [28] - The price of palm oil exports from Malaysia has decreased by 6.44% in early April [30]
花粉季的「过敏星人」,买出一个百亿爆款
36氪· 2025-04-02 23:59
Core Viewpoint - The article highlights the urgent demand for effective allergy treatments in China, driven by a significant increase in allergy cases and the corresponding rise in medication sales, indicating a burgeoning market opportunity for pharmaceutical companies [3][8][9]. Market Dynamics - The pollen concentration in Beijing has surged, leading to a 40% year-on-year increase in allergy medication purchases, with specific orders for nasal allergy medications rising by 160% [8]. - The allergy medication market in China, currently valued at a low penetration compared to global standards, is projected to exceed $20 billion by 2030 due to increasing patient awareness and payment capabilities [8][9]. Product Trends - Traditional allergy medications like Loratadine have seen a significant sales increase, with total retail sales surpassing 7.6 billion yuan in the past five years, maintaining an annual growth rate of over 10% [11][13]. - New formulations and delivery methods, such as oral liquids and syrups, are being explored by pharmaceutical companies to enhance market competitiveness [11]. Innovation in Allergy Treatments - The introduction of innovative biologics, such as Dupilumab, which targets IL-4Rα, marks a significant advancement in allergy treatment, showing promising clinical results in alleviating symptoms [17]. - The global clinical trial landscape for allergy treatments has expanded, with over 1,600 studies registered, indicating a strong focus on developing new therapies [14]. Pricing and Market Challenges - Biologics, while effective, come with high price points, which may deter patients who prefer cost-effective options. Balancing efficacy and affordability remains a challenge for companies in this sector [19][20]. - Desensitization therapy, although lengthy, is viewed as a potential long-term solution for allergy sufferers, with companies like Iwubio reporting significant sales growth in their desensitization products [21]. Future Outlook - The allergy medication market is poised for growth, with numerous companies entering the space, seeking to capitalize on the increasing demand for effective treatments [21].