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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 122 drug applications between 3 December 2022 and 9 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 22, covering 18 drug names.

2022/12/03 – 2022/12/09

Period
2022/12/03 to 2022/12/09, 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
122
Drugs with new generic filings (by drug name, de-duplicated)
18
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

122filings, 22 of them generic

By application type

Application typeFilings
Supplement64
Generic22
New drug21
Import7
Import re-registration6
Unspecified2

By drug type

Drug typeFilings
Chemical drug99
Therapeutic biologic16
TCM7

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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tedizolid Phosphate Tablets221
2Lenalidomide Capsules213
3Oseltamivir Phosphate Capsules2139
4Elagolix Sodium Tablets212
5Morinidazole and Sodium Chloride Injection119
6Salbutamol Sulfate Inhalation Solution112
7Desloratadine Tablets110
8帕拉米韦氯化钠注射液 · No verified English name1117
9Fluorouracil Injection116
10Kit For The Preparation Of Gallium Ga 68 Dotatate Injection110

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

63 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized1170
2Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized1120
3Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
4Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized430
5Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized410
6Atlantic Laboratories Corporation Ltd.310
7Janssen Research & Development LLC310
8Pfizer Inc.310
9Santen Pharmaceutical Co. Ltd.310
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized310

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

34 this week

AcceptedDrugApplicants
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200347 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200346 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200345 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Generic · Class 3 Fluorouracil InjectionCYHS2202050 Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized; Ha Yao Group Bio Gong Cheng Co., Ltd. romanized
2022/12/09Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2202049 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/12/09Generic · Class 3 Gallium[68Ga ] Dotatate InjectionCYHL2200110 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/09Generic · Class 3 Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200109 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/09New drug · Class 1 重组人CD80突变体-Fc融合蛋白注射液 · No verified English nameCXSL2200595 Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized
2022/12/09New drug · Class 1 SG1906注射液 · No verified English nameCXSL2200594 Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200934 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200933 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200932 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200931 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200930 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 RP904片 · No verified English nameCXHL2200929 Run Jia (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized
2022/12/09New drug · Class 1 RP904片 · No verified English nameCXHL2200928 Run Jia (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized
2022/12/08Generic · Class 3 Minoxidil Topical SolutionCYHS2202039 Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized
2022/12/08Generic · Class 3 Elagolix Sodium TabletsCYHL2200108 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2022/12/08Generic · Class 3 Elagolix Sodium TabletsCYHL2200107 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2022/12/08New drug · Class 1 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200593 Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized
2022/12/08New drug · Class 1 KD-025细胞注射液 · No verified English nameCXSL2200592 Nanjing Kai Di Medical Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200063 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2022/12/08New drug · Class 1 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200062 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2022/12/08New drug · Class 1 NB004片 · No verified English nameCXHL2200927 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200926 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200925 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/08New drug · Class 1 ABSK121-NX片 · No verified English nameCXHL2200924 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/07Import · Class 1 GDC-0077 · No verified English nameJXHL2200344 F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/12/07Import · Class 1 GDC-0077 · No verified English nameJXHL2200343 F.Hoffmann-La Roche Ltd
2022/12/07Generic · Class 3 帕拉米韦氯化钠注射液 · No verified English nameCYHS2202034 Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

4 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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