Core Viewpoint - The article highlights the unprecedented surge in business development (BD) activities in China's biotech sector, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, marking a doubling compared to 2024. This trend reflects the increasing global competitiveness and value of Chinese pharmaceutical assets, while also prompting a deeper examination of transaction quality and product value realization post-agreement [1][2]. Summary by Sections BD Market Dynamics - The BD market in China is experiencing a significant boom, with a projected compound annual growth rate (CAGR) for external BD activities expected to remain in double digits over the next five years, despite a forecasted decline in growth rate [2]. - Key characteristics of future transactions include an increase in late-stage pipeline contributions and a shift from pure technology transfer to models involving "licensing + co-development + commercialization" [2]. Major Transactions - Notable transactions in 2025 include: - Hengrui Medicine's collaboration with GSK, involving a total potential amount of approximately $120 billion, with an upfront payment of $500 million [3]. - Innovent Biologics' agreement with Takeda, with a potential total of $114 billion and an upfront payment of $1.2 billion [3]. - A record-setting deal between 3SBio and Pfizer, with an upfront payment of $12.5 billion and potential milestone payments reaching $48 billion [5][6]. Global Interest in Chinese Biotech - Chinese innovative drugs are gaining significant traction in global markets, with multinational corporations increasingly sourcing early-stage innovation pipelines from China due to cost-effectiveness and potential efficacy [7][8]. - The trend indicates a shift where Chinese biotech firms are evolving from technology providers to value co-creators in the global pharmaceutical landscape [7]. Transaction Models - The dominant transaction model remains "License-out," which accounted for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [10]. - NewCo models are gaining popularity, allowing companies to inject parts of their product pipelines into newly formed entities with foreign capital, reflecting a flexible asset operation strategy [10][11]. Future Outlook - The BD market is expected to continue thriving, driven by the need for multinational companies to replenish their pipelines as many blockbuster drugs face patent expirations, creating a significant market opportunity [15]. - Emerging technologies, particularly in ADCs and bispecific antibodies, are anticipated to dominate future BD transactions, with a notable interest in metabolic and autoimmune products [16][17]. Challenges and Considerations - Despite the growth, challenges remain in ensuring compliance with international standards and protecting intellectual property during global collaborations [13]. - The market is expected to stabilize, with a rational return to expectations regarding BD transactions, as the industry matures and the focus shifts from explosive growth to sustainable value creation [17].

Core Viewpoint - Fasenra (benralizumab) has received approval from the NMPA for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA), marking a significant advancement in the treatment options available for this rare autoimmune disease [1][4]. Group 1: Clinical Research and Approval - The approval is based on the results of the MANDARA global Phase III clinical trial, which is the first head-to-head study comparing the efficacy and safety of benralizumab with mepolizumab in patients with refractory EGPA [1][5]. - In the benralizumab treatment group, nearly 60% of patients achieved remission, consistent with the mepolizumab group, while 41% of patients could completely discontinue oral corticosteroids (OCS), compared to 26% in the mepolizumab group [1][5]. - The open-label extension study of the MANDARA trial showed that patients switching from mepolizumab to benralizumab had an OCS discontinuation rate of up to 43.5% [1]. Group 2: Disease Background and Treatment Challenges - EGPA is a rare autoimmune disease characterized by eosinophil infiltration and necrotizing granulomatous inflammation, primarily affecting the respiratory system and leading to severe complications if untreated [2][4]. - Current treatment options are limited, with many patients requiring high-dose OCS and experiencing frequent relapses, as approximately 75% of patients have not achieved remission despite multiple therapies [2][4]. Group 3: Expert Opinions and Future Directions - Experts highlight that benralizumab's approval represents a milestone in providing targeted therapy for EGPA, potentially improving patient outcomes and reducing reliance on corticosteroids [3][4]. - The subcutaneous administration of benralizumab every four weeks enhances treatment convenience for patients, addressing a significant need for effective and safe treatment options [3][4]. - AstraZeneca plans to continue exploring the potential of benralizumab in other eosinophil-related diseases, aiming to innovate treatment strategies in this area [3][6].

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Core Insights - European pharmaceutical investments are declining as companies shift focus to the US and China due to low R&D spending in Europe [1][2] - High-income European countries spend about half on innovative drugs compared to the US, with Europe’s share of global pharmaceutical R&D investment dropping from 41% to 31% over the past two decades [1] - In 2024, Europe’s R&D spending is expected to grow by 4.4%, significantly lower than the US's 5.5% and China's 20.7% [1] Group 1 - The decline in investment has resulted in Europe lagging behind China in new drug approvals, with the European Economic Area's share of global clinical trials halving from 22% in 2013 to 12% in 2023 [4] - Pharmaceutical companies warn that without policy adjustments, Europe risks falling further behind the US and being overtaken by China in innovation and drug access [4] - The challenges faced by pharmaceutical companies in Europe include high R&D costs and diverse national issues that complicate solutions [2] Group 2 - Trade agreements between the EU and the US have set a new tariff cap of 15% on drugs exported from the US to the EU, but it remains uncertain if this will restore investment in Europe [5] - The UK’s agreement with the US is expected to cost £3 billion and increase NHS drug spending from 9.5% to 12% of its budget, raising concerns about funding sources [5] - There are fears that if additional funding for drug spending comes from existing NHS budgets, it could lead to higher mortality rates due to the replacement of cost-effective treatments with expensive new drugs [5]

Group 1 - The 2026 China International Service Trade Fair (CIFTIS) is scheduled to be held from September 9 to 13, 2026, with participation from over 10 countries and international organizations, including Norway and the World Intellectual Property Organization [1] - Since its inception in 2012, CIFTIS has successfully held 12 sessions, attracting 1.47 million exhibitors and visitors from nearly 200 countries and regions [1] - Starting in 2025, CIFTIS will be held annually during the second week of September at Shougang Park, with a five-day duration and plans for a permanent venue upgrade [1] Group 2 - The 2026 CIFTIS will host a high-profile global service trade summit, inviting foreign dignitaries, international organization leaders, and CEOs of multinational companies to participate and speak [2] - The fair will feature specialized exhibitions in key service trade areas such as financial services, cultural tourism, education, and sports, focusing on industry trends and showcasing new technologies [2] - A new "Overseas Zone" and a small and medium-sized enterprise exhibition area will be introduced, providing platforms for showcasing service and technology exports, along with tailored services for SMEs [2] Group 3 - CIFTIS 2026 will organize various cultural, business, and tourism-related activities at distinctive venues like the Shougang Ski Jump, creating a relaxed atmosphere for business negotiations [3] - Business investigation routes will be offered to provide exhibitors with immersive service experiences [3]

Core Viewpoint - AstraZeneca announced the approval of Ipupronit Sodium Injection (brand name Wainua) in China for the treatment of adult hereditary transthyretin amyloidosis polyneuropathy (ATTRv-PN), marking a significant milestone as it is the only gene-silencing agent approved for this condition in the country [1][6]. Group 1: Approval and Treatment Benefits - The approval is based on positive results from the NEURO-TTRansform Phase III clinical study, which demonstrated consistent and sustained clinical benefits in patients treated with Ipupronit Sodium compared to a placebo over a 66-week observation period [3][8]. - Key endpoints showed improvements in serum transthyretin (TTR) levels and neuropathy impairment scores, as well as quality of life assessments, indicating the drug's effectiveness [3][8]. Group 2: Disease Context and Treatment Mechanism - ATTRv-PN is a debilitating disease that can lead to peripheral nerve damage, with patients typically experiencing motor function impairment within five years of diagnosis and an average life expectancy of ten years without treatment [4][9]. - Ipupronit Sodium is administered monthly via an automatic injector, enhancing medication convenience and potentially improving patients' quality of life [1][6]. - The drug works by upstream inhibition of TTR production in the liver, making it a promising treatment for various types of transthyretin amyloidosis [4][9]. Group 3: Global Development and Ongoing Research - Ipupronit Sodium has also been approved in the United States and the European Union, with ongoing efforts to secure approvals in more countries [5][9]. - The drug is currently undergoing the CARDIO-TTRansform Phase III clinical study to evaluate its efficacy in treating adult transthyretin cardiac amyloidosis (ATTR-CM), which is the largest clinical study of its kind with over 1,400 participants [5][9].

Core Insights - The 2026 China International Service Trade Fair (CIFTIS) is scheduled to take place from September 9 to 13, 2026, at Shougang Park, with participation from over 10 countries and international organizations, including Norway and the World Intellectual Property Organization [1][2] - The fair will feature nearly 100 Fortune 500 companies and industry leaders, such as AstraZeneca, Eli Lilly, and Siemens, expressing intent to exhibit [1] - CIFTIS has successfully hosted 12 editions, attracting 1.47 million exhibitors and visitors from nearly 200 countries and regions [1] Group 1 - The 2026 CIFTIS will continue to host a high-profile Global Service Trade Summit, inviting foreign dignitaries, international organization leaders, and CEOs of multinational companies to speak [1] - The event will also include forums and meetings to facilitate discussions, consensus-building, and result announcements among various sectors [1] Group 2 - The fair will invite various parties to set up exhibitions and hold meetings, continuing to establish guest countries and provinces, and inviting international organizations and leading enterprises to showcase their strengths [2] - Specialized exhibitions will focus on key service trade areas such as financial services, cultural tourism, education, and sports, highlighting industry trends and showcasing new technologies and applications [2] - A new "Overseas Zone" and a small and medium-sized enterprise exhibition area will be introduced, showcasing China's foreign trade, particularly in service and technology exports [2]

Core Insights - AstraZeneca and Ionis Pharmaceuticals have jointly developed Ipupronit Sodium Injection, which has been approved by the National Medical Products Administration for the treatment of adult patients with hereditary transthyretin amyloidosis polyneuropathy (ATTRv-PN) [1] - Ipupronit Sodium is the first and currently the only gene-silencing agent approved for the treatment of ATTRv-PN in China [1] Group 1: Disease Overview - ATTR is caused by the accumulation of misfolded TTR protein produced by the liver, leading to organ damage and failure, with various complications affecting cardiovascular, neurological, and renal health [2] - ATTR has multiple phenotypes, including ATTR-CM (primarily affecting the heart) and ATTRv-PN (primarily affecting the peripheral nervous system), with ATTRv-PN being a debilitating disease that can lead to motor function impairment within five years of diagnosis [2] - The average age of onset for patients in China is 42 years, with a range from 17 to 68 years, and there is a significant delay of 3 to 4 years from symptom onset to diagnosis due to low awareness among the public and healthcare professionals [2] Group 2: Treatment Insights - Ipupronit Sodium is a gene-silencing agent administered once a month, which works by upstream inhibition of TTR protein production, showing potential for treating various types of transthyretin amyloidosis [3] - The approval of Ipupronit Sodium provides new hope for ATTRv-PN patients, as clinical evidence indicates it can halt the progression of neuropathy and significantly improve neurological function and quality of life [3]

Core Viewpoint - The approval of Wainua® (eplontersen) by AstraZeneca and Ionis for the treatment of ATTRv-PN in China represents a significant advancement in addressing a previously underserved medical need for patients suffering from this debilitating disease [1] Group 1: Product Approval - Wainua® is the first and currently the only gene-silencing agent approved in China for the treatment of ATTRv-PN [1] - The drug was officially approved on December 22, 2025, marking a milestone in the treatment options available for patients [1] Group 2: Disease Impact - ATTRv-PN is a debilitating disease that can lead to peripheral nerve damage, with patients typically experiencing motor function impairment within five years of diagnosis and a general mortality rate within ten years if untreated [1] - The disease has been included in China's second batch of rare disease catalog, highlighting its significance and the need for effective treatments [1] Group 3: Expert Commentary - Professor Zhang Shuyang, the chief researcher of EPIC-ATTR in China, emphasized the long-standing impact of ATTRv-PN on patients' neurological symptoms and quality of life, noting the limited treatment options available prior to the approval of Wainua® [1]

Core Viewpoint - AstraZeneca has submitted an application for the approval of gefurulimab in China, targeting generalized myasthenia gravis (gMG) as its indication, based on clinical trial progress [1] Group 1: Product Information - Gefurulimab is a mini bispecific antibody (25kD) that includes a variable region of the antibody heavy chain targeting C5 and an antibody fragment that specifically binds to albumin [1] - The smaller molecular weight of gefurulimab allows for better permeability, and its binding to albumin extends its half-life [1] Group 2: Disease Context - Generalized myasthenia gravis (gMG) is a rare, debilitating, chronic autoimmune neuromuscular disease that leads to muscle function loss and severe weakness [2] - Initial symptoms of gMG may include slurred speech, diplopia, ptosis, and weakness, with progression leading to more severe symptoms such as extreme fatigue, difficulty swallowing, choking, and respiratory failure [2]