文 | 时代周报 近日，中药老字号企业片仔癀频现新药研发动态，相继发布了1.1类中药创新药温胆片和化学药品1类创 新药PZH2108片的研发进展情况。这家以片仔癀产品为核心的老牌中药企业，也在化药创新药研发领域 取得进展。 据片仔癀公告介绍，PZH2108片IIa期临床试验采用多中心、随机、双盲、安慰剂对照设计，以"治疗期 不良事件及安全性评估异常的发生及严重程度"作为主要终点。该临床试验方案已获得牵头单位河南省 肿瘤医院医学伦理委员会审核同意，并于2025年11月14日完成首例受试者入组。截至公告日11月21日， 该药物项目的研发投入(未经审计)累计约6100万元。 对于同类产品情况，片仔癀公告介绍，根据全球疾病负担研究数据，2021年，癌症患者中约44.5%会经 历不同程度的癌症疼痛，约有797万癌痛患者。根据2016-2021年癌症病例的发展趋势及癌痛患病率，预 计到2033年，癌痛患者数量将会突破1200万人。阿片类药物为目前癌痛的常规治疗药物。经查询药智网 数据库，2024年，中国医院销售端的镇痛阿片碱类药物销售规模达104.78亿元。 11月21日，片仔癀（600436.SH）发布公告称，近日，公 ...

Core Viewpoint - The company, Haikang (002653.SZ), announced an adjustment to its plan for issuing A-shares to specific investors for the year 2025, reducing the total fundraising cap from 1.365 billion yuan to 1.245 billion yuan to comply with regulatory requirements [1] Group 1: Fundraising Adjustment - The total amount of funds to be raised has been adjusted to not exceed 1.245 billion yuan, down from the previous cap of 1.365 billion yuan [1] - The adjustment is made to meet the regulatory requirement that the proportion of funds for supplementing working capital and repaying debts cannot exceed 30% of the total fundraising amount [1] - The funds will primarily be used for new drug research and development, with 965.26 million yuan allocated for R&D projects and 280 million yuan for working capital [1] Group 2: Financial Performance - The company's revenue for the reporting period (2022 to June 2025) was 3.015 billion yuan, 3.355 billion yuan, 3.721 billion yuan, and 2.001 billion yuan respectively [1] - Net profit figures for the same period were 392 million yuan, 296 million yuan, 466 million yuan, and 129 million yuan, indicating overall profitability [1] - As of June 2025, the R&D team has grown to over 920 members, with approximately 44% holding master's degrees or higher [1] Group 3: Drug Development Pipeline - The company has received approval for four Class 1 new drugs: Ropivacaine Injection, Clonidine Hydrochloride Capsules, Alogliptin Tablets, and Anifrolumab Injection [1] - Additionally, there are 13 Class 1 new drugs currently in clinical stages of development [1]

Market Performance - The pharmaceutical sector experienced a slight increase of +0.04% on September 15, 2025, underperforming the CSI 300 index by 0.20 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+2.54%) and medical devices (+0.48%) performed well, while vaccines (-0.91%), medical consumables (-0.72%), and blood products (-0.51%) lagged behind [1] - Top three gainers in individual stocks were Furuide (+20.01%), Dezhan Health (+10.02%), and Zhaoyan New Drug (+10.01%), while the biggest losers were Nuocheng Jianhua (-8.20%), Yinkang Life (-5.21%), and Xinnuo Wei (-5.11%) [1] Industry News - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for the oral peptide therapy Icotrokinra (JNJ-2113), developed in collaboration with Protagonist, aimed at treating moderate to severe plaque psoriasis in patients aged 12 and older [2] - The ICONIC-LEAD pivotal Phase 3 study reported positive topline results, indicating that Icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis and demonstrated good safety [2] Company News - Kanglong Chemical announced that its subsidiary, Kanglong Shaoxing, successfully passed the FDA's on-site quality inspection, marking the first time its Shaoxing active pharmaceutical ingredient production facility has passed the FDA's pre-approval inspection [3] - Haisco received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection, which has been approved for an additional indication to treat moderate to severe itching in adult patients with chronic kidney disease related to maintenance hemodialysis [3] - Yipinhong's subsidiary in Guangzhou received a drug registration certificate for Clindamycin Palmitate Granules, confirming compliance with registration requirements [3] - Shanghai Laishi announced that its controlling shareholder, Haiyingkang, has cumulatively increased its shareholding by 72,935,300 shares, representing 1.10% of the total share capital, with a total investment of approximately RMB 499.99 million from May 22, 2025, to September 15, 2025 [3]

Group 1 - China Shenhua reported coal sales of 37.5 million tons in August, a year-on-year decrease of 3.1%, with total sales for the first eight months at 280 million tons, down 9.2% year-on-year [1] - China Shenhua, established in November 2004, focuses on coal and electricity production and sales, as well as transportation and coal-to-olefins [1] - Huaren Shuanghe's subsidiary received a drug registration certificate for a new injection used in treating non-ST elevation acute coronary syndrome [1] - Huaren Shuanghe, founded in May 1997, operates in chronic disease management, specialty business, and infusion business [1] Group 2 - New Wufeng's subsidiary signed a property transaction contract for a 60% equity transfer at a price of 9.7 million yuan [1] - New Wufeng, established in June 2001, specializes in pig farming, meat sales, and feed processing [2] - Yaoshi Technology announced that its convertible bonds will stop conversion after September 17, with remaining bonds to be redeemed at 100.62 yuan per bond [3] - Yaoshi Technology, founded in December 2006, focuses on drug molecular building blocks and related services [3] Group 3 - Newhua Co. announced a board member's plan to reduce holdings by up to 75,200 shares, representing 0.039% of total shares [4] - Newhua Co., established in September 1997, specializes in fine chemical products [4] - Hefei Construction's subsidiary signed a land use rights transfer contract for residential land with a total price of 12.24 billion yuan [6] - Hefei Construction, founded in September 1999, is involved in real estate development and property management [6] Group 4 - Guoyao Modern's subsidiary received a drug registration certificate for an injection used in anesthesia and emergency treatment [7] - Guoyao Modern, established in November 1996, focuses on pharmaceutical product development and sales [7] - Maohua Shihua announced the resignation of its deputy general manager [8] - Maohua Shihua, founded in October 1988, specializes in petrochemical products [9] Group 5 - Zhejiang Xineng applied for enforcement of a civil mediation agreement, seeking 170 million yuan from a group for breach of contract [10] - Zhejiang Xineng, established in December 1991, focuses on renewable energy projects [10] - Zejing Pharmaceutical announced the initiation of key clinical trials for a new drug targeting DLL3 [11] - Zejing Pharmaceutical, founded in March 2009, specializes in the development and production of new chemical and biological drugs [12] Group 6 - Huayi Technology's deputy general manager resigned due to personal work arrangements [13] - Huayi Technology, established in December 1998, focuses on high polymer materials and equipment manufacturing [13] - Luxiao Technology's subsidiary signed a strategic cooperation agreement with a leading cross-border e-commerce company [14] - Luxiao Technology, founded in May 1989, operates in various sectors including photovoltaic power generation [14] Group 7 - Aoxiang Pharmaceutical's subsidiary received a drug registration certificate for a new cancer treatment [15] - Aoxiang Pharmaceutical, established in April 2010, focuses on the development and production of pharmaceutical products [15] - Baiyunshan's pharmaceutical factory received approval for five drug supplement applications [16] - Baiyunshan, founded in September 1997, specializes in the research and production of various pharmaceutical products [16] Group 8 - Renfu Pharmaceutical's subsidiaries received drug registration certificates for two new products [17] - Renfu Pharmaceutical, established in March 1993, focuses on drug research and production [18] - China Shipbuilding Technology signed a significant contract for green methanol sales, potentially worth up to 1.2 billion dollars [19] - China Shipbuilding Technology, founded in May 1997, specializes in wind and solar resource development [19] Group 9 - Haohua Technology received a project designation from a global automotive brand for its ADAS system [20] - Haohua Technology, established in January 2010, focuses on intelligent driving perception systems [20] - Hendi Pharmaceutical received approval for a new raw material drug [21] - Hendi Pharmaceutical, founded in December 1995, specializes in chemical raw materials and formulations [22] Group 10 - JX Communication's subsidiary received a temporary use permit for an air traffic communication system [23] - JX Communication, established in January 1995, focuses on communication technology applications [23] - Longyuan Technology's deputy general manager resigned due to work reasons [24] - Longyuan Technology, founded in December 1998, specializes in energy-saving and environmental protection [25] Group 11 - Jiuqiang Bio received a medical device registration for a gastrin-17 assay kit [26] - Jiuqiang Bio, established in January 2001, focuses on in vitro diagnostic testing platforms [26] - Rifei Co. received approval for a stock issuance to specific investors [27] - Rifei Co., founded in December 2009, specializes in special equipment cables and other electrical devices [27] Group 12 - Huayi Media received a subsidy for a micro-short drama project [28] - Huayi Media, established in August 1998, focuses on film and game content investment [28] - Huilong Pharmaceutical's subsidiary received overseas marketing approvals for multiple products [29] - Huilong Pharmaceutical, founded in October 2010, specializes in innovative and high-quality generic drugs [29] Group 13 - Junsheng Electronics' subsidiary received project designations from two major automotive brands [30] - Junsheng Electronics, established in August 1992, focuses on automotive parts [30] - Silek signed an investment cooperation agreement for a new energy project [31] - Silek, founded in January 2004, specializes in metal packaging equipment [31] Group 14 - ST Huhuwa received drug registration certificates for two new products [32] - ST Huhuwa, established in June 2005, focuses on drug research and production [32] - Canray Technology announced a share buyback plan of 20 to 40 million yuan [33] - Canray Technology, founded in September 2005, specializes in integrated circuits [33] Group 15 - Qilu Bank's directors plan to collectively increase their holdings by at least 3.5 million yuan [34] - Qilu Bank, established in June 1996, focuses on corporate and personal banking services [34] - China Overseas Land reported a significant decrease in contract sales in August [35] - China Overseas Land, founded in September 1997, specializes in tourism and real estate [35] Group 16 - Longjian Co. plans to acquire 100% of Guangdong Zhimao's equity for 40,000 yuan [36] - Longjian Co., established in January 1993, focuses on infrastructure construction [36] - Lichong Group's subsidiary received project designations from a luxury car brand [37] - Lichong Group, founded in July 1998, specializes in aluminum alloy products [37] Group 17 - Kanglong Huacheng's subsidiary passed an FDA inspection [38] - Kanglong Huacheng, established in July 2004, focuses on integrated drug research and development services [38] - Kangtai Bio received a drug registration certificate for a new polio vaccine [39] - Kangtai Bio, founded in September 1992, specializes in vaccine development and production [39] Group 18 - Baiyunshan's pharmaceutical factory's drug entered a key clinical trial phase [40] - Baiyunshan, established in September 1997, focuses on various pharmaceutical products [40] - Zhongyuan Home's chairman plans to reduce holdings by up to 3% [41] - Zhongyuan Home, founded in November 2001, specializes in furniture production [41] Group 19 - Shangluo Electronics plans to acquire 88.79% of Ligon Technology's equity for 709 million yuan [42] - Shangluo Electronics, established in August 1999, focuses on electronic components [42] - Shangluo Electronics also plans to issue convertible bonds to raise 1 billion yuan [43] - Shangluo Electronics, founded in August 1999, specializes in electronic products for various applications [43] Group 20 - HNA Holdings reported a 3.38% increase in passenger capacity in August [44] - HNA Holdings, established in December 1995, focuses on air transportation services [44] - Yipin Hong's subsidiary received a drug registration certificate for a new product [45] - Yipin Hong, founded in February 2002, specializes in pharmaceutical production [45] Group 21 - Haishi Ke's innovative drug received approval for a new indication [46] - Haishi Ke, established in August 2005, focuses on new drug development [46] - Huaxia Airlines plans to repurchase shares worth 80 to 160 million yuan [47] - Huaxia Airlines, founded in April 2006, specializes in air transportation services [47] Group 22 - Jingchen Co. plans to acquire 100% of Xinchip Microelectronics for 316 million yuan [48] - Jingchen Co., established in July 2003, focuses on semiconductor design [48] - Zhongxin Heavy Industry was recognized as an excellent smart factory by the Ministry of Industry and Information Technology [49] - Zhongxin Heavy Industry, founded in January 2008, specializes in large equipment and technology solutions [49]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, Anruikefen Injection (HSK21542), which is indicated for treating moderate to severe pruritus in adult patients undergoing maintenance hemodialysis [1][2]. Group 1: Drug and Application Information - Drug Name: Anruikefen Injection - Acceptance Number: CXHS2400097 - Certificate Number: 2025S02878 - Approval Number: National Drug Standard H20250014 - Application: Drug registration (domestic production) - Registration Category: Class 1 chemical drug - Dosage Form: Injection - Specification: 1ml: 0.1mg - Indication: For moderate to severe pruritus in adult patients with chronic kidney disease undergoing maintenance hemodialysis [1]. Group 2: R&D Project Overview - HSK21542 is a highly selective peripheral kappa opioid receptor agonist developed by the company - Clinical research indicates that HSK21542 Injection significantly alleviates pruritus, with primary and secondary efficacy indicators showing significant improvement over the placebo group - The safety profile of HSK21542 Injection is reported to be good and controllable - The newly approved indication was included in the priority review and approval process in July 2024 and is now approved for market release, providing better options for patients suffering from pruritus - Anruikefen Injection was first approved in May 2025 for treating mild to moderate pain after abdominal surgery, and a Phase III clinical study for its use in postoperative pain relief in orthopedic surgery is ongoing [2].

Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, HSK21542, which is expected to provide better options for patients suffering from itching [1] Company Summary - HSK21542, marketed as Anruikefen Injection (brand name: Sishujing), is a highly selective peripheral kappa opioid receptor agonist developed independently by the company [1] - Clinical research indicates that HSK21542 significantly alleviates itching, with both primary and secondary efficacy indicators showing substantial improvement over the placebo group [1] - The safety profile of HSK21542 injection is reported to be good and controllable [1] Industry Summary - The newly approved indication for HSK21542 will be included in the priority review and approval process in July 2024, highlighting the drug's potential impact on the market [1] - The approval of HSK21542 is expected to enhance treatment options for patients, indicating a positive development in the pharmaceutical industry focused on innovative therapies [1]

Core Viewpoint - The company Haishi Ke (002653) has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for its injection drug Anruikefen (brand name: Sishujing, R&D code: HSK21542), which is indicated for the treatment of moderate to severe itching associated with chronic kidney disease in adult patients undergoing maintenance hemodialysis [1]. Group 1 - The drug Anruikefen has been approved for a new indication related to chronic kidney disease [1]. - The approval highlights the company's ongoing commitment to developing innovative treatments for patients with specific medical needs [1].

Core Viewpoint - The company has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection (brand name: Sishujing, R&D code: HSK21542), with a new indication for treating moderate to severe itching related to chronic kidney disease in adult patients undergoing maintenance hemodialysis [1] Group 1 - The drug Anruikefen is now approved for a new indication, expanding its potential market [1] - The approval highlights the company's commitment to developing innovative treatments for chronic conditions [1] - This development may enhance the company's competitive position in the pharmaceutical industry [1]

Core Viewpoint - The company Haisco (002653.SZ) has received approval from the National Medical Products Administration for its innovative drug Anruikefen injection, which now includes a new indication for treating moderate to severe itching associated with chronic kidney disease in adult patients undergoing maintenance hemodialysis [1] Group 1 - The newly approved indication for Anruikefen injection will be included in the priority review and approval process starting from July 2024 [1] - Anruikefen injection was first approved in May 2025 for the indication of treating mild to moderate pain after abdominal surgery [1] - Phase III clinical trials for the indication of postoperative analgesia in orthopedic surgery are currently progressing smoothly [1]

Macro and Strategy - The equity market is currently in an accelerating upward phase, prompting discussions on how to adjust positions to prepare for potential market fluctuations [8] - Investors are advised to consider right-side position reduction as a more reasonable choice, given the current market dynamics [8] - Historical data suggests that low-priced convertible bonds (priced between 110-115 yuan) tend to be more resilient during market downturns [8] Company and Industry Analysis - **Dengkang Dental (001328.SZ)**: The company reported a stable growth in Q2 2025, with revenue reaching 842 million yuan, a year-on-year increase of 19.72%, and a net profit of 85 million yuan, up 17.59% [10][11] - **Marubi Biotechnology (603983.SH)**: The company achieved a revenue of 1.769 billion yuan in H1 2025, a 30.83% increase year-on-year, while net profit grew by 5.21% to 186 million yuan [13][14] - **Haidi Lao (06862.HK)**: The company reported a revenue of 20.7 billion yuan in H1 2025, a decrease of 3.7%, with core operating profit down 14% [17][18] - **Green Tea Group (06831.HK)**: The company achieved a revenue of 2.29 billion yuan in H1 2025, a 23.1% increase, with adjusted net profit rising by 40% [19][20] - **Haisco Pharmaceutical (002653.SZ)**: The company reported a revenue of 2 billion yuan in H1 2025, an 18.6% increase, with anesthetic product revenue growing by 54% [22][23] - **Furui Co., Ltd. (300049.SZ)**: The company achieved a revenue of 713 million yuan in H1 2025, an 11.02% increase, while net profit was impacted by foreign exchange losses [26][27] - **Kaili Medical (300633.SZ)**: The company reported a revenue of 964 million yuan in H1 2025, a decrease of 4.78%, with net profit down 72.43% due to high initial investments in new product lines [29][30] - **Yuyue Medical (002223.SZ)**: The company reported a revenue of 4.659 billion yuan in H1 2025, an 8.2% increase, with net profit rising by 7.4% [31][32]