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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 26 December 2022 and 1 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 54 drug names.

2022/12/26 – 2023/01/01

Period
2022/12/26 to 2023/01/01, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
54
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

394filings, 82 of them generic

By application type

Application typeFilings
Supplement214
Generic82
New drug78
Import9
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug285
TCM64
Therapeutic biologic39
Biologic4
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection518
2Esmolol Hydrochloride Injection333
3Clindamycin Injection314
4Remifentanil Hydrochloride for Injection312
5Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
6Gadobutrol Injection318
7Gadoteric Acid Meglumine Salt Injection311
8Vildagliptin Tablets220
9Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II)223
10Macitentan Tablets223

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Lang De Pharma Co., Ltd. romanized32160
2Fresenius Kabi Deutschland GmbH2420
3Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized15150
4Xian Tang Chen Pharmaceutical Co., Ltd. romanized850
5Qi Yuan Bio (Hangzhou) Co., Ltd. romanized810
6Yi Chang Ren Fu Pharma Co., Ltd. romanized736
7Jilin Te Yan Pharma Co., Ltd. romanized550
8Jiangxi Xin Zheng Pharma Co., Ltd. romanized550
9Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized515
10Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized440

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

124 this week

AcceptedDrugApplicants
2023/01/01New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2200641 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/12/31Import · Class 2.4 Ganaxolone口服混悬剂 · No verified English nameJXHL2200354 Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2022/12/31Generic · Class 3 Diprophylline InjectionCYHS2202175 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/12/31Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2202174 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2022/12/31New drug · Class 2.2; 2.3 淫羊藿苷元胶囊 · No verified English nameCXZL2200057 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2022/12/31New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2200095 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2022/12/31New drug · Class 1 CM355 · No verified English nameCXSL2200640 Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized
2022/12/31New drug · Class 1 注射用RS2102 · No verified English nameCXSL2200639 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2022/12/31New drug · Class 1 注射用MHB036C · No verified English nameCXSL2200638 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1 C5252疱疹病毒注射液 · No verified English nameCXSL2200637 Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/12/31New drug · Class 1 IO-108注射液 · No verified English nameCXSL2200636 Yi Ming Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1.3 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) · No verified English nameCXSL2200635 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized
2022/12/31New drug · Class 1 注射用MHB088C · No verified English nameCXSL2200634 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2200633 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/12/31New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2200632 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/12/31New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200991 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/12/31New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200990 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/12/31New drug · Class 1 HX101胶囊 · No verified English nameCXHL2200989 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/12/31New drug · Class 1 RJ4287片 · No verified English nameCXHL2200988 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/12/31New drug · Class 1 RJ4287片 · No verified English nameCXHL2200987 Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized
2022/12/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200986 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200985 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200984 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1 QY211凝胶 · No verified English nameCXHL2200983 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/12/31New drug · Class 1 伊匹乌肽滴眼液 · No verified English nameCXHL2200982 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
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

94 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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