YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 4 June 2025 and 10 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 63 drug names.

2025/06/04 – 2025/06/10

Period
2025/06/04 to 2025/06/10, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
52

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

335filings, 96 of them generic

By application type

Application typeFilings
Supplement150
Generic96
New drug64
Import16
Unspecified6
Import re-registration3

By drug type

Drug typeFilings
Chemical drug220
TCM55
Therapeutic biologic53
Prophylactic biologic4
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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection6553
2Safinamide Methansulfonate Tablets4220
3Dapagliflozin Tablets4284
4Sodium Nitroprusside Injection3215
5Minoxidil Liniment3252
6Paliperidone Palmitate Injection318
7Ethyl Iosapentate Capsules2227
8Pioglitazone and Metformin Hydrochloride Tablets2210
9Glucosamine Sulfate Capsules2251
10Sevelamer Carbonate Powder for oral suspension223

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

238 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qilu Pharmaceutical Co., Ltd.541
2Shandong Qidu Pharmaceutical Co., Ltd.433
3Bayer AG420
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
5Jiangsu Hao Sen Pharma Group Co., Ltd. romanized420
6Eli Lilly Nederland B.V.410
7Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized410
8Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized330
9Zun Yi Hua Wei Pharmaceutical Co., Ltd. romanized330
10Merck Sharp & Dohme B.V.320

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

112 this week

AcceptedDrugApplicants
2025/06/10Import · Class 1 Muvalaplin片 · No verified English nameJXHL2500131 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/06/10Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502047 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502046 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 Acetylcysteine InjectionCYHS2502043 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 Acetylcysteine InjectionCYHS2502042 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 布洛芬去氧肾上腺素片 · No verified English nameCYHS2502033 Kang Zhi Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2502032 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 Ciclosporin Eye Drops(Ⅱ)CYHL2500108 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 2.3 金振口服液 · No verified English nameCXZL2500038 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/06/10New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2500061 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized
2025/06/10New drug · Class 1 GR1802注射液 · No verified English nameCXSL2500470 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 1 GR1802注射液 · No verified English nameCXSL2500469 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 1.2 NT-INF-001制剂 · No verified English nameCXSL2500468 Jia Yi Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/06/10New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500467 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 注射用QLS31905 · No verified English nameCXSL2500466 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 HRS-6093片 · No verified English nameCXHL2500550 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/10New drug · Class 1 HRS-6093片 · No verified English nameCXHL2500549 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/10New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500548 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500547 Qilu Pharmaceutical Co., Ltd.
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

82 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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