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一品红左卡尼汀口服溶液获注册证书 近期已有多款药品获批
Core Viewpoint - Yipinhong (300723) has received approval from the National Medical Products Administration for its oral solution of L-carnitine, indicating a significant step in expanding its product portfolio in the pharmaceutical market [1] Group 1: Product Approvals - Yipinhong's subsidiary has obtained a drug registration certificate for L-carnitine oral solution, which is indicated for primary systemic carnitine deficiency and related symptoms [1] - The approved L-carnitine oral solution is classified as a Category B product under the national medical insurance, with an estimated sales scale of approximately 1.257 billion yuan in 2024 [1] - In addition to L-carnitine, Yipinhong has received approvals for several other drugs, including escitalopram oxalate drops (estimated sales of 1.88 billion yuan in 2024) and clindamycin palmitate ester granules (estimated sales of 100 million yuan in 2024) [2][2] - The company has also received approval for oseltamivir phosphate capsules, which are used for the treatment and prevention of influenza in adults and children [2] Group 2: Innovative Drug Development - Yipinhong has disclosed that its innovative drug APH03621, a GnRH receptor antagonist for endometriosis treatment, has received clinical trial registration acceptance [3] - The company is advancing its gout drug AR882, with global Phase III clinical trials expected to complete enrollment by August 2025, and data from these trials anticipated in 2026 [3]
医药太平洋医药日报:强生口服多肽 ICOTROKINRA向欧盟递交上市申请
Xin Lang Cai Jing· 2025-09-17 00:30
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]
股市必读:一品红(300723)9月16日主力资金净流出4563.91万元
Sou Hu Cai Jing· 2025-09-16 17:48
Group 1 - The stock price of Yipinhong (300723) closed at 60.35 yuan on September 16, 2025, down 2.99% with a turnover rate of 1.55% and a trading volume of 64,800 shares, amounting to a transaction value of 393 million yuan [1] - On September 16, the net outflow of main funds was 45.6391 million yuan, while the net inflow from speculative funds and retail investors was 21.6322 million yuan and 24.0069 million yuan, respectively [1][3] Group 2 - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., received a drug registration certificate for Clindamycin Palmitate Granules from the National Medical Products Administration. This drug is classified as a Category 3 chemical drug with a specification of 1.5g and a shelf life of 48 months [1] - The drug is indicated for severe infections caused by sensitive anaerobic bacteria, streptococci, pneumococci, and staphylococci, particularly for patients allergic to penicillin. The product is also a Category B product under the national medical insurance scheme and is considered to have passed the consistency evaluation [1] - The expected sales scale of this drug in urban and county-level public hospitals in China for 2024 is approximately 100.3 million yuan. The approval of this product will enhance the company's product pipeline and strengthen its competitiveness in the anti-infection field [1]
9月16日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-16 10:15
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]
一品红(300723.SZ):子公司获得盐酸克林霉素棕榈酸酯颗粒注册证书
Ge Long Hui A P P· 2025-09-15 12:01
Core Viewpoint - Yipinhong (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has received the drug registration certificate for Clindamycin Palmitate Hydrochloride Granules from the National Medical Products Administration [1] Group 1: Product Approval - The drug is indicated for severe infections caused by sensitive anaerobic bacteria [1] - Clindamycin is also suitable for severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use by a physician [1] - The approved instructions include specific dosage and administration guidelines for children [1] Group 2: Mechanism of Action - Clindamycin works by inhibiting bacterial protein synthesis through binding to the 23S rRNA of the 50S ribosomal subunit [1]
一品红:子公司获得盐酸克林霉素棕榈酸酯颗粒注册证书
Ge Long Hui· 2025-09-15 11:57
Group 1 - The core point of the article is that Yipinhong (300723.SZ) has received approval from the National Medical Products Administration for the drug registration certificate of Clindamycin Palmitate Granules, indicating a significant development for the company [1] - The approved indication for Clindamycin is for serious infections caused by sensitive anaerobic bacteria, as well as infections caused by sensitive strains of Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use by a physician [1] - The product's instruction clearly includes dosage and administration guidelines for children, highlighting its applicability in pediatric medicine [1] Group 2 - Clindamycin functions as an antibacterial drug by inhibiting bacterial protein synthesis through binding to the 23S rRNA of the 50S ribosomal subunit [1]
一品红(300723.SZ):盐酸克林霉素棕榈酸酯颗粒获注册证书
智通财经网· 2025-09-15 11:03
Core Viewpoint - The company Yipinhong (300723.SZ) has received approval from the National Medical Products Administration for the drug registration certificate of Clindamycin Palmitate Granules, indicating a significant advancement in its product offerings [1] Company Summary - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has been granted the drug registration certificate for Clindamycin Palmitate Granules [1] - Clindamycin is indicated for severe infections caused by sensitive anaerobic bacteria and is suitable for patients allergic to penicillin or those deemed unsuitable for penicillin by a physician [1]
一品红:全资子公司获盐酸克林霉素棕榈酸酯颗粒注册证书
Xin Lang Cai Jing· 2025-09-15 11:00
Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug registration certificate of Clindamycin Palmitate Granules, indicating a significant advancement in its pharmaceutical offerings [1] Group 1: Product Approval - The full subsidiary of the company, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has recently obtained the drug registration certificate for Clindamycin Palmitate Granules [1] - Clindamycin is indicated for severe infections caused by sensitive anaerobic bacteria, as well as infections caused by sensitive strains of Streptococcus, Pneumococcus, and Staphylococcus [1] - The product is specifically indicated for patients who are allergic to penicillin or those deemed unsuitable for penicillin by a physician, with clear dosage instructions for pediatric use included in the product's labeling [1]