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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 24 December 2022 and 30 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 51 drug names.

2022/12/24 – 2022/12/30

Period
2022/12/24 to 2022/12/30, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
51
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

301filings, 76 of them generic

By application type

Application typeFilings
Supplement146
Generic76
New drug56
Import15
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug229
TCM39
Therapeutic biologic28
Biologic3
In vitro diagnostic reagent1
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection518
2Clindamycin Injection314
3Remifentanil Hydrochloride for Injection312
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
5Gadobutrol Injection318
6Gadoteric Acid Meglumine Salt Injection311
7Esmolol Hydrochloride Injection223
8Vildagliptin Tablets220
9Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II)223
10Voriconazole Tablets211

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

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Deutschland GmbH2420
2Xian Tang Chen Pharmaceutical Co., Ltd. romanized850
3Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized770
4Yi Chang Ren Fu Pharma Co., Ltd. romanized736
5Jilin Te Yan Pharma Co., Ltd. romanized550
6Qilu Pharmaceutical Co., Ltd.531
7Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized515
8Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized440
9Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized424
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420

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

102 this week

AcceptedDrugApplicants
2022/12/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2202164 Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2022/12/30Generic · Class 3 Pregabalin Oral SolutionCYHS2202161 Jian Min Pharma Group Co., Ltd. romanized
2022/12/30Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2202157 Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized
2022/12/30Generic · Class 3 Timolol Maleate Eye DropsCYHS2202154 Jiangsu Yuan Heng Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Timolol Maleate Eye DropsCYHS2202153 Jiangsu Yuan Heng Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2202150 Nanjing Ming Sheng Pharmaceuticals Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/12/30Generic · Class 3 Sulfamethoxazole and Trimethoprim InjectionCYHS2202148 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHS2202147 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHS2202146 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Remifentanil Hydrochloride for InjectionCYHS2202145 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/30Generic · Class 3 Clindamycin InjectionCYHS2202144 Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2022/12/30Generic · Class 3 Clindamycin InjectionCYHS2202143 Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2022/12/30Generic · Class 3 Clindamycin InjectionCYHS2202142 Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2022/12/30Generic · Class 3 Hydrotalcite SuspensionCYHS2202141 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2022/12/30New drug · Class 1.1 芩翘咽舒颗粒 · No verified English nameCXZL2200056 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized
2022/12/30New drug · Class 1 西达基奥仑赛注射液 · No verified English nameCXSS2200094 Nanjing Chuan Qi Bio Technology Co., Ltd. romanized
2022/12/30New drug · Class 1 BA1105注射液 · No verified English nameCXSL2200631 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/12/30New drug · Class 1 STSA-1002注射液 · No verified English nameCXSL2200630 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2022/12/30New drug · Class 1 JS010注射液 · No verified English nameCXSL2200629 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/30New drug · Class 1 HH-003注射液 · No verified English nameCXSL2200628 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2022/12/30New drug · Class 1 注射用LM-302 · No verified English nameCXSL2200627 Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized
2022/12/30New drug · Class 1 KP104注射液 · No verified English nameCXSL2200626 Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/12/30New drug · Class 1 BRY805注射液 · No verified English nameCXSL2200625 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2022/12/30New drug · Class 1 CS0159片 · No verified English nameCXHL2200981 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/12/30New drug · Class 1 CS0159片 · No verified English nameCXHL2200980 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/12/30New drug · Class 2.2 Meloxicam injectionCXHL2200979 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2022/12/30New drug · Class 1 LS21031胶囊 · No verified English nameCXHL2200978 Suzhou Lan Cheng Pharmaceuticals Co., Ltd. romanized
2022/12/30New drug · Class 1 LS21031胶囊 · No verified English nameCXHL2200977 Suzhou Lan Cheng Pharmaceuticals Co., Ltd. romanized
2022/12/30New drug · Class 2.2 复方盐酸替利定缓释片 · No verified English nameCXHL2200976 Hebei Ao Xing Group Pharma Co., Ltd. romanized
2022/12/30New drug · Class 2.2 卡托普利口服溶液 · No verified English nameCXHL2200975 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized

72 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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