Centralized Drug Procurement Again Sparks Controversy (AI Translation)
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文｜财新周刊 周信达 滑昂
By Caixin Weekly's Zhou Xinda and Hua Ang
2024年12月13日，第十批国家组织药品集中带量采购结果已尘埃落定，但这场史上最高降幅风暴给中国仿制药行业的震动远未消散。
On December 13, 2024, the results of the tenth batch of state-organized drug bulk procurement have been finalized, but the shockwaves of this unprecedented price-cutting storm have yet to subside in China's generic drug industry.
时隔一年的集采聚集了更多玩家。涉及62种药品，申报企业439个，产品778个，覆盖高血压、糖尿病、肿瘤、心脑血管疾病、感染、精神疾病等领域，注射剂过半，数量创下历史新高。最终234家企业的385个产品获得拟中选资格，中选率49.5%。
The collective procurement after a year's hiatus has attracted even more players. The process involved 62 types of drugs, with 439 companies submitting 778 products, covering fields such as hypertension, diabetes, cancer, cardiovascular and cerebrovascular diseases, infections, and mental illnesses. More than half of these were injections, setting a historical record in numbers. Ultimately, 385 products from 234 companies secured provisional selection, with a winning rate of 49.5%.
由于参与企业数量众多且增加了一道“复活”机制，第十批集采的阵线格外漫长，受理企业提交材料及开标从早上8点一直持续到傍晚。过程同样跌宕起伏。作为一家老牌仿制药企的市场准入负责人，王宇（化名）参与了每一次集采开标现场，这次他所在企业的阿司匹林肠溶片成功中选。他告诉财新，在唱标环节许多企业的报价念出来后，大家都很错愕，甚至阵阵叹息，推测部分中选产品价格基本上就在该产品成本线附近。
Due to the high number of participating companies and the addition of a "revival" mechanism, the tenth round of centralized procurement was particularly prolonged, with the submission of materials by companies and the opening of bids stretching from 8 a.m. to late afternoon. The process was equally tumultuous. Wang Yu (a pseudonym), a market access manager at a well-established generic drug company, was present at each procurement bid opening. This time, his company's enteric-coated aspirin successfully won the bid. He told Caixin that during the bid announcement phase, many were shocked by the disclosed prices, with audible sighs throughout the room, suggesting that some winning bid prices were virtually at the cost line of the products.
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- The tenth batch of China's state-organized drug bulk procurement resulted in unprecedented price cuts, attracting 439 companies submitting 778 products, with a 49.5% success rate, including significant price reductions on several drugs.
- Regulatory changes, particularly affecting Type B certificate companies, have intensified competition, leading to extremely low bids, raising concerns about profitability and drug quality.
- Concerns persist over the quality and efficacy of low-priced generics, despite efforts to ensure consistency; ongoing debates focus on the impact of these procurement practices on the pharmaceutical industry's sustainability.
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[para. 21][para. 27] Ensuring drug quality amidst these cost cuts has sparked ongoing debate. Concerns persist over central procurement's quality, safety, and efficacy assurances, as studies show that, clinically, generic drugs often match their original counterparts. Yet, some experts are skeptical of the study designs, arguing for more comprehensive research. Ensuring stringent compliance with manufacturing standards and government vigilance in inspections and evaluations is vital to maintain public confidence in the generics produced under these procurement schemes. The shift in regulatory approach demands cohesive, multidimensional strategies from authorities to streamline production quality and regulatory oversight.
- Cisen Pharmaceutical
辰欣药业 - Cisen Pharmaceutical, in collaboration with Harbin Sanlian, secured the lowest bid for potassium chloride injection (10ml: 1.5g*1) at 0.16 yuan in the tenth round of national drug procurement in China.
- Harbin Sanlian Pharmaceutical
哈尔滨三联 - Harbin Sanlian Pharmaceutical is mentioned in the article as one of the companies winning a bid for potassium chloride injection (10ml: 1.5g*1 unit) with the lowest selected price of 0.16 yuan, alongside Chenxin Pharmaceutical.
- Zhejiang Jingxin Pharmaceutical
浙江京新 - Zhejiang Jingxin Pharmaceutical successfully won the bid for aspirin enteric-coated tablets in the latest national drug procurement round. They offered a price of 2.06 yuan for a package of 100mg tablets (30 tablets per board, 2 boards per box), translating to just 0.034 yuan per tablet.
- Sichuan Haimeng Zhisen Biopharmaceutical
四川海梦智森生物制药 - Sichuan Haimeng Zhisen Biopharmaceutical participated in China's 2024 national drug procurement, offering a remarkably low price for the gastrointestinal antispasmodic drug, Trimethoprim injection, at 0.22 yuan (40mg in 4ml), representing a price reduction of approximately 92%. The drug will be produced by Taiji Group Sichuan Taiji Pharmaceutical. The firm's low pricing strategy suggests an effort to capture market share despite minimal profit margins.
- Taiji Group Sichuan Taiji Pharmaceutical
太极集团四川太极制药 - Taiji Group Sichuan Taiji Pharmaceutical was mentioned for producing the lowest-priced competitive bid for the drug Anisodamine injection (4ml: 40mg) at 0.22 yuan per unit. The company was responsible for manufacturing under a bid won by Sichuan Haimeng Zhisen Biopharmaceutical. This aggressive pricing during the procurement process was suggested to have been aimed at capturing market share, even at marginal profitability.
- Nanjing Daoqun Pharmaceutical
南京道群 - Nanjing Daoqun Pharmaceutical participated in the tenth batch of national drug procurement in China, successfully securing a bid for aspirin enteric-coated tablets. They achieved this with the second-lowest price of 1.11 Chinese Yuan for a box containing 30 tablets, equating to 0.037 Yuan per tablet. The production of these tablets is outsourced to Nanjing BaiJingYu Pharmaceutical.
- Nanjing Baijingyu Pharmaceutical
南京白敬宇制药 - Nanjing Baijingyu Pharmaceutical was mentioned in the context of the tenth batch of national drug procurement in China. The company was involved in producing aspirin enteric-coated tablets, with a low bid price of 1.11 yuan for a box containing 100mg tablets (10 tablets per board × 3 boards/box), equating to 0.037 yuan per tablet. The production for them was contracted to Nanjing Daqun.
- MSD
默沙东 - In the article, MSD (Merck & Co.) is mentioned as one of the originator drug companies that did not win bids in the recent centralized drug procurement in China. MSD, along with other companies like Boehringer Ingelheim and UCB, reportedly submitted bids that were symbolically low and far exceeded the comparable price limit, indicating a possible strategic decision not to compete aggressively in the tender.
- Boehringer Ingelheim
勃林格殷格翰 - Boehringer Ingelheim participated in China's tenth batch of drug procurements but was not selected. The company bid for telmisartan hydrochlorothiazide tablets at a price of 37.39 yuan, far above the group's lowest selected price, effectively signaling a strategic decision to withdraw from the highly competitive bidding dominated by significantly lower prices.
- UCB
优时比 - The article mentions that the original research pharmaceutical company UCB did not win any bids in China's tenth batch of national drug procurement despite participating. This indicates that their bid prices may not have been competitive enough compared to those from domestic generic drug companies.
- Astellas Pharma
安斯泰来 - According to the article, Astellas Pharma was among the original drug companies that did not win any bids in the tenth round of China's national drug procurement. The process saw significant price reductions, with some prices dropping by over 80%. This suggests that companies like Astellas did not meet the aggressive pricing targets set by this procurement round.
- CSPC Ouyi Pharmaceutical
石药集团欧意药业 - CSPC Ouyi Pharmaceutical is one of the seven companies that won the bid for aspirin enteric-coated tablets in the latest round of centralized drug procurement in China. They offered a bid price with the lowest winning price for 100mg aspirin tablets at just 0.0343 to 0.048 yuan per tablet.
- Chongqing Yaoyou Pharmaceutical
重庆药友 - Chongqing Yaoyou Pharmaceutical was among the 7 companies that won the bid for aspirin enteric-coated tablets. The bidding revealed significantly low prices, with each aspirin tablet being priced as low as 0.0343 yuan to 0.048 yuan, raising concerns over cost coverage and potential quality issues in the production of such low-priced generics.
- Bayer
拜耳 - The article mentions Bayer's original branded drug Acarbose (known as Glucobay) in the context of the "suicidal pricing" strategy during China's second round of centralized drug procurement in 2020, where it offered a bid of 0.18 yuan per tablet. Moreover, it highlights Bayer's withdrawal from continued procurement contracts following diminished sales and revenue impacts.
- Luye Pharma
绿叶制药 - The article mentions that Luye Pharma was one of the companies participating in the competition for the original drug Acarbose tablet (brand name: Glucobay) during the second round of centralized procurement in 2020. Despite Bayer's original Acarbose tablet winning with a low bid, Luye and other companies were surprised by the significantly reduced price.
- Sino-American Huadong Pharmaceutical
中美华东 - Sino-American Huadong Pharmaceutical was mentioned in the context of the 2020 second batch procurement, where Bayer's original drug acarbose tablets (Bayetanping) won against companies like Sino-American Huadong, surprising the industry with a low price of 0.18 yuan per tablet, highlighting the intense competition and pricing pressure in China's pharmaceutical market.
- December 2019：
- China officially launched the Marketing Authorization Holder (MAH) system.
- By the end of 2023：
- Nearly 40% of pure Category B certificated companies had yet to obtain drug marketing approvals.
- June 2024：
- As of the end of June 2024, the number of Category B certificated companies nationwide reached 1,246.
- December 13, 2024：
- The results of the tenth batch of state-organized drug bulk procurement were finalized.
- In the early morning of the day following the close of bidding：
- The list of selected candidates for the centralized procurement appeared on the Shanghai Sunshine Medical Procurement Network.
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