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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 156 drug applications between 28 April 2024 and 4 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 36 drug names.

2024/04/28 – 2024/05/04

Period
2024/04/28 to 2024/05/04, 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
156
Drugs with new generic filings (by drug name, de-duplicated)
36
Accepted this week, now under review
0

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

156filings, 44 of them generic

By application type

Application typeFilings
Supplement68
Generic44
New drug29
Import re-registration8
Unspecified5
Import2

By drug type

Drug typeFilings
Chemical drug91
TCM38
Therapeutic biologic24
Biologic2
Prophylactic biologic1

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Pregabalin Oral Solution315
3Fluvoxamine Maleate Tablets220
4Perindopril arginine and amlodipine besylate tablets213
5复方聚乙二醇电解质散(Ⅱ) · No verified English name214
6Moxifloxacin Hydrochloride Eye Drops214
7Itraconazole Oral Solution111
8Diquafosol Sodium Eye Drops115
9Perindopril arginine and amlodipine besylate tablets110
10Perindopril Arginine and Amlodipine Besylate Tablets(III)113

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

106 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized12120
2Shenyang Xing Qi Yan Yao Co., Ltd. romanized810
3BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED440
4Shaanxi Jun He Run Kang Pharma Co., Ltd. romanized440
5Jiangxi Shimei Pharmaceutical Co., Ltd434
6Takeda Pharmaceutical Company Limited410
7Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized330
8Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized320
9Hainan Si Da Pharmaceutical Co., Ltd. romanized313
10Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized313

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

49 this week

AcceptedDrugApplicants
2024/05/01Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400084 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/05/01New drug · Class 1 CNK-UT002细胞注射液 · No verified English nameCXSL2400284 Yi Zun Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2024/05/01New drug · Class 1 注射用sacituzumab tirumotecan · No verified English nameCXSL2400283 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/05/01New drug · Class 1 酒石酸泰贝西利胶囊 · No verified English nameCXHS2400039 Bei Da Pharma Co., Ltd. romanized
2024/05/01New drug · Class 1 SGB-3908注射液 · No verified English nameCXHL2400426 Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized
2024/05/01New drug · Class 2.2 HZ031口溶膜 · No verified English nameCXHL2400425 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2024/04/30Import · Class 1 ASP2138注射液 · No verified English nameJXSL2400083 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/04/30Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2401322 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2024/04/30Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2401319 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/04/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2401318 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 硫酸沙丁胺醇糖浆 · No verified English nameCYHS2401315 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401314 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Bilastine Oral SolutionCYHS2401313 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401312 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401311 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Epinephrine InjectionCYHS2401310 Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized
2024/04/30Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2401309 CISEN PHARMACEUTICAL CO., LTD.
2024/04/30Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401308 Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401307 Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Azithromycin Eye DropsCYHL2400080 Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/30New drug · Class 1.1 清降和胃颗粒 · No verified English nameCXZL2400022 Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400282 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400281 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 注射用sacituzumab tirumotecan · No verified English nameCXSL2400280 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400279 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400278 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 PM8002注射液 · No verified English nameCXSL2400277 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/04/30New drug · Class 1 PM1009注射液 · No verified English nameCXSL2400276 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400275 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400274 Shenyang Xing Qi Yan Yao Co., Ltd. romanized

19 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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