Core Viewpoint - Junshi Biosciences announced the acceptance of the new drug application (NDA) for roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody designed to treat moderate to severe plaque psoriasis by targeting the inflammatory pathway associated with the disease [1][6]. - The NDA submission is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy and a favorable safety profile [3][4]. Clinical Study Insights - The phase 3 clinical study showed that treatment with roconkibart for 12 weeks resulted in significant improvements in the Psoriasis Area and Severity Index (PASI) scores and static Physician Global Assessment (sPGA) scores compared to the placebo group [4]. - The efficacy of roconkibart was maintained throughout a 52-week treatment period, indicating its potential as a long-term treatment option for patients [4]. Market Implications - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5]. - The company aims to collaborate closely with regulatory authorities to expedite the product's market approval process [5].

Core Viewpoint - Junshi Biosciences has received acceptance for the new drug application (NDA) of roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi Biosciences has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody injection designed to treat adult patients with moderate to severe plaque psoriasis [1][6]. - The drug works by selectively blocking IL-17A, a cytokine involved in the inflammatory pathway of psoriasis, thereby alleviating symptoms of autoimmune diseases [6]. Clinical Study Insights - The NDA is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy in improving psoriasis severity scores compared to placebo [3][4]. - Results indicated that treatment with roconkibart for 12 weeks led to substantial improvements in the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) scores, with a favorable safety profile maintained over 52 weeks [4]. Future Prospects - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5].

Group 1: Major Transactions - Bohai Chemical is planning to sell 100% equity of Tianjin Bohai Petrochemical and acquire control of Anhui Taida New Materials through a combination of share issuance and cash payment, leading to a significant asset restructuring [1] - Zhongneng Electric is set to acquire 65% equity and debt from three companies, which may constitute a major asset restructuring but will not involve share issuance or change in control [4] - Hai Tai Development has decided to terminate the acquisition of controlling interest in Zhixueyun Technology due to disagreements on key terms, ensuring no adverse impact on normal business operations [5] Group 2: Performance Updates - Wen's shares reported a sales revenue of 3.324 billion yuan from meat chickens in November, marking a year-on-year increase of 10.18% [6] - Shuguang shares saw a 71.07% year-on-year increase in vehicle sales, totaling 207 units in November [6] - Muyuan shares experienced a decline in sales revenue from commodity pigs, reporting 9.39 billion yuan, a decrease of 20.43% year-on-year [6] - Pengding Holdings reported a 5.58% year-on-year decrease in consolidated revenue for November [6] Group 3: Industry Developments - Xiangxi Dairy reported a 6.3% month-on-month increase in fresh milk production in November, although it saw a year-on-year decline of 6.47% [7] - Baisheng Intelligent plans to acquire 51% equity in Zhongke Shengu, which focuses on the research and application of core technologies for embodied intelligent robots [7]

上纬新材：拟2600万元购买智元创新ARM嵌入式软件及通信中间件软件代码使用权 上纬新材公告称，公司拟与关联方智元创新签订《许可协议》，智元创新将其拥有的"ARM嵌入式软件 及通信中间件软件代码"授权公司使用，公司将支付智元创新合计2600万元的授权使用费。该交易构成 关联交易，但不构成重大资产重组。公司具身智能机器人业务当前处于开发阶段，尚未实现量产及规模 化销售，预计不会对2025年度业绩产生正向影响。公司目前已组建具身智能机器人研发团队，专注于面 向个人与家庭场景的产品开发（未面向工商业领域）。公司与关联方智元创新各自独立开展具身智能机 器人业务，应用场景不同，确保与关联方不构成重大不利影响的实质同业竞争。具身智能机器人行业发 展迅速，公司面临竞争加剧、技术迭代加速等巨大挑战，为加快产品开发速度，有必要通过本次交易， 进一步缩短产品开发周期，提升在新业务领域的综合竞争力。 今日焦点渤海化学：筹划出售渤海石化100%股权并购买泰达新材控制权，股票12月8日起停牌 渤海化学公告称，公司正在筹划出售天津渤海石化有限公司100%股权、通过发行股份及支付现金的方 式购买安徽泰达新材料股份有限公司的控制权。本次交易 ...

Core Viewpoint - Junshi Biosciences has received the acceptance notice from the National Medical Products Administration for its new drug application of Rocabotamab injection, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The product Rocabotamab is a recombinant humanized anti-IL-17A monoclonal antibody injection [1] - The acceptance of the new drug application marks a significant step for Junshi Biosciences in expanding its product portfolio in the dermatology sector [1] - As of the announcement date, all participants in the Phase II clinical study of Rocabotamab for treating active ankylosing spondylitis have completed treatment and entered the safety follow-up period [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。 本公告由上海君實生物醫藥科技股份有限公司（「本公司」）自願作出。請亦參見本 公司於2025年12月5日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」）欣然宣佈，近日，本公司收到國家藥品監督 管理局核准簽發的《受理通知書》，本公司產品偌考奇拜單抗注射液（重組人源化 抗IL-17A單克隆抗體注射液，產品代號：JS005）用於治療適合系統治療或光療的 中度至重度斑塊狀銀屑病的成人患者的新藥上市申請獲得受理。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 自願性公告－ 偌考奇拜單抗注射液新藥上市申請獲得受理 研究結果顯示，偌考奇拜單抗治療12周顯著改善了銀屑病面積與嚴重程度指數 (PASI)75/90/100和靜態醫師全面評估(sPGA)評分0或1，療效顯著優於安慰劑 ...

Core Viewpoint - Junshi Biosciences (01877) has received acceptance for its new drug application for the injection of Rocabotilumab, a recombinant humanized anti-IL-17A monoclonal antibody, aimed at treating moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy [1] Group 1 - The National Medical Products Administration has issued an acceptance notice for the new drug application of Rocabotilumab [1] - Rocabotilumab is a specific anti-IL-17A monoclonal antibody developed by the company [1] - IL-17A is a multifunctional cytokine closely related to the development of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] Group 2 - Rocabotilumab works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting the activation of downstream signaling pathways and the release of inflammatory factors [1] - As of the date of the announcement, all participants in the Phase II clinical study of Rocabotilumab for the treatment of active ankylosing spondylitis have completed treatment and entered the safety follow-up period [1]

Core Viewpoint - Junshi Biosciences has received a notice of acceptance from the National Medical Products Administration for its new drug application for JS005, a monoclonal antibody injection for treating moderate to severe plaque psoriasis in adults [1] Drug Information - Drug Name: JS005 (Rocacitinib Injection) - Application Type: Domestic production drug registration and marketing license - Acceptance Numbers: CXSS2500129, CXSS2500130 - Applicant: Junshi Biosciences - Specifications: 150mg (1ml) per pre-filled syringe and 150mg (1ml) per pre-filled autoinjector [1] - Approval Conclusion: The application has been accepted following the review under Article 32 of the Administrative Licensing Law of the People's Republic of China [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之內容概不負責，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。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於偌考奇拜單抗注射液新藥上市申請 獲得受理的公告》，僅供參閱。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國，上海，2025年12月5日 於本公告日期，本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士；非執行董事湯毅先 生；以及獨立非執行董事張淳先生、馮曉源博士、酈仲賢先生、魯琨女士及楊勁 博士。 * 僅供識別之用 证券代码：688180 证券简称：君实生物 公告编号：临 2025-071 （於中華人民共和國註冊成立的股份有限公司） ...

Core Viewpoint - The strategic collaboration between Innovent Biologics and Takeda Pharmaceutical has officially commenced, marking a significant milestone in China's innovative drug industry with a potential deal value of up to $11.4 billion, setting a record for Chinese innovative drugs going global [1][3]. Group 1: Collaboration Details - Innovent Biologics will receive an upfront payment of $1.2 billion, which includes a $100 million strategic equity investment and up to $10.2 billion in milestone payments [1]. - The collaboration focuses on the global development and commercialization of next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies, specifically IBI363 and IBI343, along with early-stage project IBI3001 [1][7]. - IBI363 is recognized as one of the fastest-developing PD-1/IL-2 products globally, with ongoing clinical trials, including a pivotal Phase III study for squamous non-small cell lung cancer [6][10]. Group 2: Market Position and Financial Performance - Innovent Biologics has become one of the largest biopharmaceutical companies in China since its establishment in 2011, with a diverse product portfolio covering oncology, autoimmune diseases, metabolism, and ophthalmology [10]. - The company reported a revenue of 5.953 billion yuan in the first half of the year, a 50.6% year-on-year increase, and achieved profitability with a profit of 834 million yuan [11]. - As of the end of July, Innovent had over 14 billion yuan in cash reserves, positioning itself well for future growth and development [10].