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中药饮片质量问题频出,11项国家炮制规范草案细化质量标准
Xin Jing Bao· 2025-06-19 14:19
6月17日-18日,国家药典委公示了11项国家中药饮片炮制规范草案,分别对11种中药饮片在炮制、性 状、贮藏方面进行了明确规范。新京报记者注意到,今年以来,中药饮片质量问题频出。多地药品抽检 信息显示,中药饮片成为药品抽检不合格的"重灾区"。 以半边莲为例,炮制规范草案明确介绍了其炮制方法,"取药材,去除杂质,枪水洗净、切段,干燥, 筛去碎屑";其性状为"本品呈不规则的段。根及根茎细小,表面淡棕黄色或黄色。茎细,无毛,节明 显。叶无毛,无柄,叶片多皱缩、绿褐色,狭披针形,椭圆状披针形或线形,全缘或边缘具舒而浅的 齿,顶部有明显的齿。气特异,味甘而辛";贮藏"置干燥处"。 此前,6月6日,甘肃省药监局也发布了《关于发布沉香曲等4个甘肃省中药炮制规范的公告》,涉及品 种为沉香曲、雾水葛、薄树芝和灵芝孢子粉,自发布之日起实施。甘肃省药监局对上述四款中药饮片的 炮制,从炮制、性状、鉴别、检查、浸出物、含量测定、性味与归经、功能与主治、用法用量、贮藏等 进行了详细规范,从地方层面为中药饮片质量管控助力。 江西省药监局今年以来也发布了4期药品抽检信息公告。6月9日最新发布的药品抽检信息显示,18批产 品不符合规定,其中包 ...
上市失败案例分析:那些倒在IPO路上的企业做错了什么?
Sou Hu Cai Jing· 2025-06-06 10:08
美国上市|中概股|IPO|赴美上市|赴港上市|专业赴美上市服务机构 近年来,中概股赴美、赴港上市持续呈现热潮,但审核结果呈现明显分化态势。随着各个证券监管部门对上市资质审查日趋严格,部分拟上市企业主动 暂缓或撤销上市计划。 中国证监会发行审核委员会做出的否决发行上市申请、取消已发行申请的审核、撤销已通过的核准这三项决策,对企业来说均属于"上市失败",更有企 业多次"上市失败"。 华谊信资本根据以往的上市失败案例及相关资料,总结了企业IPO失败的几大缘由,希望可以给企业一些启发。 财务压力与债务危机 作为AI领域的高新技术企业,滴普科技在2025年4月递交港股IPO申请时,已连续三年累计亏损24亿元,资产负债率高达965.3%,现金储备仅能覆盖一年 运营成本。 其财务风险主要体现在:第一,产生流动性危机,短期偿债能力严重不足;第二,研发投入收缩,研发开支占营收比例骤降,研发人员流失率约40%; 第三,商业模式缺陷,营收增长近九成却亏损扩大,销售费用为研发投入两倍,暴露"重销售轻研发"的战略失衡。监管机构对其内部控制有效性提出质 疑,如劳务外包合规性问题,最终导致IPO进程受阻。 估值分歧与行业周期下行 2025 ...
中药饮片集采落地市场格局生变:订单激增利润超预期 600家中标企业赢者通吃
Xin Lang Zheng Quan· 2025-06-05 01:31
Core Insights - The national collection of traditional Chinese medicine (TCM) decoction pieces is accelerating in about 10 provinces, indicating a significant transformation in the industry chain [1] - Despite a sharp drop in raw material costs leading to unexpectedly high profits for companies, only 600 out of 2300 licensed enterprises have won bids, signaling a deep restructuring of the industry [1][3] Group 1: Market Dynamics - The demand surge due to the implementation of centralized procurement is expected to peak around October, with many winning companies facing capacity constraints [2] - The price index for Chinese medicinal materials has dramatically decreased from a high of 2253 points in July 2024 to 1756 points by the end of May this year, with major varieties like Codonopsis and Licorice seeing price drops of 30%-55% [2] - The centralized procurement has locked in hospital purchase prices, allowing the reduction in raw material costs to translate directly into profit margins, contrasting sharply with last year's pessimistic profit outlook [2] Group 2: Industry Restructuring - Only about 600 winning companies will share the benefits of centralized procurement, which is less than one-third of the total licensed enterprises, indicating a significant industry reshuffle [3] - The value of upstream production areas is becoming more prominent, with policies favoring "fresh processing" and "source tracing," allowing regional companies to break through multi-variety procurement restrictions [3] - The distribution landscape is changing, with traditional markets facing pressure and pharmaceutical companies accelerating their shift towards upstream production areas, particularly in Yunnan and Gansu [3] - The market share is increasingly concentrating among leading companies, as the exclusivity of centralized procurement will reduce the number of suppliers, benefiting larger firms with scale and supply chain advantages [3] Group 3: Future Outlook - The roadmap for the industry is becoming clearer, with expectations that the number of centralized procurement varieties will exceed 100 this year and potentially cover 200-300 commonly used decoction pieces in the next two to three years [3] - The binding of medical insurance payments with centralized procurement is likely to accelerate the shrinking survival space for non-winning enterprises [3][4]
中药饮片集采进入“精耕期”,行业上下游深度洗牌
邓勇向21世纪经济报道记者指出,首先在质量评判标准方面,化学药、生物药等的质量评判标准相对明 确和统一,有严格的化学成分、纯度、生物活性等指标,且这些指标可以通过科学仪器进行精确检测和 量化。而中药饮片的质量评判更为复杂,其质量受到中药材的产地、种植方式、采收时间、炮制工艺等 多种因素影响。因此,中药饮片联采在质量标准制定上,除了要符合药典标准外,还需要考虑更多的因 素,如道地性、炮制规范等。 公开信息显示,目前全国约有超2300家企业具备中药饮片生产资格。在政策推动下,医疗机构往往会优 先选用集采中标产品,未中标产品的市场空间被持续压缩,直至淡出交易市场,行业集中化趋势逐渐显 著。 21世纪经济报道记者唐唯珂广州报道中药饮片集采继续按下加速键。 5月以来,中药饮片集采落地进程加速,约10个省份开始落实第一次全国中药饮片集采的中标结果。 公开信息显示,本轮中药饮片集采覆盖黄芪、党参等45个临床常用品种,是首轮联采的2倍,3万余家医 药机构需求量合计达9700多万公斤。珍宝岛(603567)药业共2448个品规中选,华润现代中药共有超 2500个品规入围,九隆现代中药入围品规约为2100余个。 北京中医药大学卫 ...
新荷花几度A股IPO未果,转战赴港上市前景几何?
Sou Hu Cai Jing· 2025-06-04 10:33
以信为眼, 洞察财经世界 00 0 4-17 几度铃羽而归,新荷 花再闯港交所。 近年来,多次闯关A股未果后再闯港交所的公司愈发增加,四川新荷花中药饮片股份有限公司(下 称"新荷花")便是其中之一。 成立于2001年的新荷花,是我国第一家中药饮片GMP(药品生产质量管理规范)工厂,主营产品包括 毒性饮片、普通饮片。公司业务遍布中国境内大部分省份,并在海外扩展到中医药需求强劲的地区,如 越南和马来西亚。 可作为中药饮片的头部企业,为何会多次闯关A股均未果?现如今又正式转战港股,又将迎来怎样的命 运? 在资本市场的征途中,新荷花的A股上市之路可谓是充满了坎坷与挑战。这家在中药饮片领域有着深厚 积累的企业,多次冲击A股上市,却屡战屡败,引发了市场的广泛关注和深入探讨。 新荷花在2011年11月25日创业板发审委工作会议上通过审核,但2012年过会后不久,就遭到员工举报, 称其存在财务造假行为,包括隐瞒关联交易、虚增企业利润等严重内控治理问题。尽管时任保荐机构和 申报会计师进行了核查并发表明确意见,监管机构也未对新荷花进行处罚,但这些举报问题仍让市场对 其财务数据的真实性产生怀疑,最终新荷花于2012年8月底撤回申请 ...
3000亿中药饮片赛道竞速:解码“港交所中药饮片第一股”新荷花
华尔街见闻· 2025-05-20 03:33
当现代 技术重构传统炮制工艺、 标准化和便捷性的中药治疗需求持续增长后,中药饮片行业 正经历 从 "经验传承"到"科学验证"的质变 , 这也推动了行业资本化时刻的到来。 作为国内最全面的中药饮片商之一 , 四川新荷花中药饮片股份有限公司 ( 下称 " 新荷花 ") 已于 近期向港交所递交上市申请,其可 提供超过 770 种的品种、 4900 个规格的中药饮片,几乎涵盖了 中药行业所使用的主要药物。 由于当前港股市场暂无主营全品类中药饮片的公司上市,新荷花若成功登陆港股,有望成为 "港交所 中药饮片第一股"。这 不仅是一家中药 饮片 企业的资本化进程,更 是 中医药现代化转型的鲜活样 本。 作为中国第二大中药饮片供应商, 新荷花以 "核心中药市场的领导地位 + 面向现代消费者的颠覆性 创新"双支柱战略,构建起传统与现代交融的产业生态 , 成为中药饮片现代化进程的重要脚注。 紧握 市场 变革的脉络 新荷花能够稳坐中药饮片龙头的地位,正是因为其始终紧握 市场 变革的 四大脉络:集采的 "优质优 价"、细分渠道、行业专业化、健康管理需求变迁。 变革一: 近年来, 政策端 对中医药产业的扶持力度持续加码,为中药饮片的标 ...
中药饮片龙头新荷花递表港交所 近三年收入复合年增长率达27%
Zheng Quan Ri Bao Wang· 2025-04-27 09:47
中药素来被誉为中华民族的瑰宝,也是大健康产业的重要组成部分,在疾病治疗和养生保健中发挥着独特作用,市场基础 广泛且下游需求稳定。2025年3月20日,相关部门发布《关于提升中药质量促进中医药产业高质量发展的意见》,明确提出加 快推进中药产业转型升级,进一步从政策层面加码扶持行业发展。 政策利好催化下,中药企业在做强做大的过程中不但积极出海,推动民族品牌走向世界,也将登陆资本市场作为全球化布 局的关键环节。4月3日,四川新荷花中药饮片股份有限公司(以下简称"新荷花")向港交所递交了招股书,拟于主板挂牌,广 发香港、农银国际担任联席保荐人。资料显示,新荷花是国内中药饮片头部企业,为大量机构和零售客户提供传统草药配方、 健康产品和健康管理服务。 中药饮片赛道长坡厚雪 新荷花为行业标准化打样 受益于加工方法的技术进步和对中药治疗需求不断增长,近年来,作为广泛使用的中药形式,中药饮片取得了长足发展, 前景一片大好。根据弗若斯特沙利文的资料,中药饮片在2023年拥有人民币2,788亿元的庞大市场,成为2023年增长最快的医 药细分行业,分别实现14.6%的收入增长和22.9%的利润增长。同时,由于全球对中药预防保健价值的 ...
新荷花港股IPO:财务造假疑云未散,毛利率下滑成掣肘
Bei Jing Shang Bao· 2025-04-16 07:04
Core Viewpoint - Sichuan Xin He Hua Chinese Medicine Co., Ltd. is attempting to list on the Hong Kong Stock Exchange after multiple failed IPO attempts, highlighting significant underlying issues that need to be addressed [1][5]. Financial Performance - Xin He Hua's revenue for 2022, 2023, and 2024 is approximately 780 million, 1.146 billion, and 1.249 billion yuan respectively, with corresponding net profits of 77.4 million, 104 million, and 89.1 million yuan [3]. - The company is experiencing a decline in profit margins, with gross profit margin decreasing from 21.1% in 2022 to 17.1% in 2024, particularly in toxic medicinal slices, which fell from 29.7% to 19.1% [3]. - The operating cash flow for 2024 is reported at -46,700 yuan, with trade receivables amounting to 5.58 billion yuan, representing 44.7% of revenue, indicating cash flow pressure [5]. Company Background - Established in 2001 and headquartered in Chengdu, Xin He Hua is one of the largest suppliers of Chinese medicinal slices, ranking second in China by revenue in 2023 [3]. - The company has a diverse product range, including toxic and ordinary medicinal slices, with operations extending beyond China to countries like Vietnam and Malaysia [3]. IPO History - Xin He Hua's IPO journey has been tumultuous, with the first attempt in 2010 being halted due to allegations of financial fraud, which claimed that a significant portion of its revenue was derived from fictitious transactions [4]. - The company made another attempt in 2020 but withdrew its application due to concerns over its core product competitiveness and internal controls [4]. Industry Challenges - The Chinese medicinal slice industry faces challenges such as price volatility in raw materials, which directly impacts pricing and costs [6]. - Xin He Hua's reliance on a limited product range poses risks; any changes in market demand or supply chain disruptions could significantly affect its performance [6].
中药饮片企业新荷花四闯IPO 递表港交所
Mei Ri Jing Ji Xin Wen· 2025-04-15 15:49
Core Viewpoint - The company Sichuan Xinhehua Traditional Chinese Medicine Decoction Pieces Co., Ltd. is making its fourth attempt to go public in Hong Kong, despite previous setbacks and ongoing challenges in the market and operational performance [1][7]. Company Overview - Established in 2001, Xinhehua is the first GMP factory for traditional Chinese medicine decoction pieces in China and one of the largest in the country [1]. - The company offers approximately 770 types of traditional Chinese medicine decoction pieces, including both common and toxic varieties [2]. Financial Performance - Xinhehua's revenue has shown consistent growth over the years, with reported revenues of 780 million yuan, 1.146 billion yuan, and 1.249 billion yuan for the years 2022, 2023, and 2024 respectively [3]. - However, net profit growth has lagged behind revenue growth, with net profits of 77 million yuan, 104 million yuan, and 89 million yuan for the same years, indicating a decline of 14.24% in 2024 compared to the previous year [3][4]. Profitability Metrics - The company's gross margin has been declining, recorded at 21.1%, 18.5%, and 17.1% for the years 2022, 2023, and 2024 respectively [4]. - The decrease in gross margin is attributed to a higher sales proportion to medical trade companies and pharmacies, which typically have lower profit margins [4]. Research and Development - Xinhehua's R&D investment has been decreasing as a percentage of total revenue, with figures of 1.23%, 0.92%, and 1.37% for the years 2022, 2023, and 2024 respectively [6]. - The number of R&D personnel has also decreased relative to total employees, with only 3.57% of the workforce engaged in R&D as of 2024 [6]. Market Dynamics - The traditional Chinese medicine market in China reached a size of 451.6 billion yuan in 2023, with expectations to grow to 599.3 billion yuan by 2030 [2]. - The decoction pieces segment is the fastest-growing sub-sector, with a market size of 278.8 billion yuan in 2023 [2]. Competitive Landscape - The industry is characterized by low concentration, with 2,334 licensed manufacturers and the top five players holding only 2.7% of the market share [3]. - Xinhehua holds a mere 0.4% market share, positioning it as the second-largest producer in the sector [3]. Regulatory Environment - The company faces increasing quality demands due to the expansion of centralized procurement for traditional Chinese medicine decoction pieces, which has led to higher scrutiny and quality control measures [9]. - Xinhehua has faced multiple quality issues, being listed by the National Medical Products Administration for non-compliance on several occasions [10].
年入12亿,四川成都中药饮片巨头冲刺IPO,上市之路坎坷
格隆汇APP· 2025-04-10 11:15
年入12亿,四川成都中药饮片巨头冲刺IPO,上市之路坎坷 原创 阅读全文 格隆汇新股 ...