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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 269 drug applications between 3 June 2025 and 9 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 53 drug names.

2025/06/03 – 2025/06/09

Period
2025/06/03 to 2025/06/09, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
269
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
46

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

269filings, 79 of them generic

By application type

Application typeFilings
Supplement113
Generic79
New drug53
Import15
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug175
Therapeutic biologic45
TCM43
Biologic3
Prophylactic biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets4220
2Dapagliflozin Tablets4284
3Acetylcysteine Injection3353
4Sodium Nitroprusside Injection3215
5Minoxidil Liniment3252
6Paliperidone Palmitate Injection318
7Pioglitazone and Metformin Hydrochloride Tablets2210
8Sevelamer Carbonate Powder for oral suspension223
9Tadalafil Tablets2123
10Folic acid injection211

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly Nederland B.V.410
2Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized410
3Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized330
4Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized330
5Merck Sharp & Dohme B.V.320
6Novartis Pharma AG320
7Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized320
8Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized320
9Li Zhu Group Li Zhu Pharmaceutical Factory romanized313
10Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized310

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

94 this week

AcceptedDrugApplicants
2025/06/09Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2502028 Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2025/06/09New drug · Class 1.1 郁枢达片 · No verified English nameCXZS2500025 Guo Yao Group Tong Ji Tang (Guizhou) Pharmaceutical Co., Ltd. romanized
2025/06/09New drug · Class 1 脐带血巨核细胞注射液 · No verified English nameCXSL2500465 Suzhou Xue Ji Bio Technology Co., Ltd. romanized
2025/06/09New drug · Class 1 人羊膜间充质干细胞注射液 · No verified English nameCXSL2500464 Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized
2025/06/09New drug · Class 1 盐酸匹米替尼胶囊 · No verified English nameCXHS2500063 Mo Ke Xue Lan Nuo (Beijing) Pharmaceuticals Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/06/07Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500073 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/07Import · Class 2.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500072 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2025/06/07Import · Class 1 Quabodepistat片 · No verified English nameJXHL2500130 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/07Import · Class 1 JSB462片 · No verified English nameJXHL2500129 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/07Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2502023 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/06/07Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2502022 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/06/07Generic · Class 3 Folic acid injectionCYHS2502020 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/06/07Generic · Class 3 Folic acid injectionCYHS2502019 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/06/07Generic · Class 3 Bilastine Oral SolutionCYHS2502018 Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2025/06/07Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502016 Hunan Jiudian Pharmaceutical Co., Ltd
2025/06/07Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500107 Zhejiang Sha Pu Health Management Co., Ltd. romanized
2025/06/07New drug · Class 1.1 益胃消瘀颗粒 · No verified English nameCXZL2500037 Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized; Name not romanized
2025/06/07New drug · Class 1.1 复方黄杞颗粒 · No verified English nameCXZL2500036 Zhejiang Jiu Ru Pharmaceuticals Technology Co., Ltd. romanized
2025/06/07New drug · Class 1 HJY-ATRQβ-001注射液 · No verified English nameCXSL2500463 Wuhan Hua Ji Yuan Bio Technology Kai Fa Co., Ltd. romanized
2025/06/07New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2500460 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/06/07New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2500459 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/06/07New drug · Class 1 注射用SSS50 · No verified English nameCXSL2500458 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/06/07New drug · Class 1 注射用LM-24C5 · No verified English nameCXSL2500457 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/06/07New drug · Class 2.4 赖诺普利氨氯地平片 · No verified English nameCXHS2500062 Sichuan Shang Rui Biopharmaceuticals Co., Ltd. romanized; Sichuan Mei Da Kang Pharma Co., Ltd. romanized
2025/06/07New drug · Class 1 注射用HTMC0769 · No verified English nameCXHL2500546 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/06/07New drug · Class 1 HSK47977片 · No verified English nameCXHL2500545 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/06/07New drug · Class 1 HSK47977片 · No verified English nameCXHL2500544 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/06/06Import · Class 1 Clesrovimab注射液 · No verified English nameJXSS2500071 Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd.
2025/06/06Import · Class 1 JSB462片 · No verified English nameJXHL2500128 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/06Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500127 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

64 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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