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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 316 drug applications between 15 May 2023 and 21 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.

2023/05/15 – 2023/05/21

Period
2023/05/15 to 2023/05/21, 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
316
Drugs with new generic filings (by drug name, de-duplicated)
38
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

316filings, 51 of them generic

By application type

Application typeFilings
Supplement188
Generic51
New drug48
Import15
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug194
TCM83
Therapeutic biologic34
Biologic3
Prophylactic biologic2

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets4112
2Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
3Indobufen Tablets226
4腺苷钴胺胶囊 · No verified English name228
5Isoprenaline Hydrochloride Injection217
6Naloxone Hydrochloride Injection211
7Dapoxetine Hydrochloride Tablets2120
8硫酸特布他林口服溶液 · No verified English name214
9Carbocisteine Oral Solution216
10Fluvoxamine Maleate Tablets210

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

149 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized64630
2Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized24120
3Ping Guang Pharmaceutical Co., Ltd. romanized14140
4AbbVie Inc.620
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
6Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized414
7Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized410
8Shandong Qidu Pharmaceutical Co., Ltd.410
9Tian Sheng Pharmaceutical Group Co., Ltd. romanized320
10Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized323

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

88 this week

AcceptedDrugApplicants
2023/05/19Import · Class 1 Cenerimod片 · No verified English nameJXHL2300122 Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd
2023/05/19Import · Class 1 Aficamten片 · No verified English nameJXHL2300121 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Import · Class 1 Aficamten片 · No verified English nameJXHL2300120 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301360 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/05/19Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301359 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/05/19Generic · Class 3 Digoxin InjectionCYHS2301354 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/05/19Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2301353 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized
2023/05/19Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2301351 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2023/05/19New drug · Class 1 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300359 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2023/05/19New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2300358 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/05/19New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2300357 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/05/19New drug · Class 1 靶向GPRC5D嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2300356 Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized
2023/05/19New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2300355 Chengdu Ou Lin Bio Technology Co., Ltd. romanized
2023/05/19New drug · Class 1 注射用QLF3108 · No verified English nameCXSL2300354 Qilu Pharmaceutical Co., Ltd.
2023/05/19New drug · Class 1 KL590586胶囊 · No verified English nameCXHL2300541 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/05/19New drug · Class 1 KL590586胶囊 · No verified English nameCXHL2300540 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/05/19New drug · Class 1 KL590586胶囊 · No verified English nameCXHL2300539 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/05/19New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300538 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/05/19New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300537 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/05/18Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2300096 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/05/18Generic · Class 3 Indobufen TabletsCYHS2301349 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Indobufen TabletsCYHS2301348 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/05/18Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2301346 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2301345 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Carbocisteine Oral SolutionCYHS2301344 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Carbocisteine Oral SolutionCYHS2301343 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Amisulpride Oral SolutionCYHS2301342 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2023/05/18New drug · Class 3.2 尼妥珠单抗注射液 · No verified English nameCXSS2300035 Bai Tai Bio Pharma Co., Ltd. romanized
2023/05/18New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300353 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/05/18New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300352 Zhejiang Dao Er Bio Technology Co., Ltd. romanized

58 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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