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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 276 drug applications between 30 July 2022 and 5 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 45 drug names.

2022/07/30 – 2022/08/05

Period
2022/07/30 to 2022/08/05, 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
276
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
1

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

276filings, 64 of them generic

By application type

Application typeFilings
Supplement135
Generic64
New drug40
Import24
Unspecified9
Import re-registration3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug209
TCM34
Therapeutic biologic27
Prophylactic biologic3
Biologic2
In vitro diagnostic reagent1

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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ozagrel Sodium Injection423
2Urapidil Hydrochloride Injection426
3Dopamine Hydrochloride Injection323
4硫酸特布他林雾化吸入用溶液 · No verified English name321
5Bortezomib For Injection221
6Propofol Medium And Long Chain Fat Emulsion Injection213
7头孢呋辛酯干混悬剂 · No verified English name215
8Paracetamol Suppositories210
9Empagliflozin Tablets2118
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

142 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized44430
2Novartis Pharma AG1060
3Hebei Wu Luo Pharma Co., Ltd. romanized970
4Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized810
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.636
6Celgene Corporation610
7Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized530
8Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized440
9Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized424
10Hainan Pu Li Pharmaceutical Co., Ltd. romanized422

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

80 this week

AcceptedDrugApplicants
2022/08/05Import · Class 1 BMS-986256胶囊 · No verified English nameJXHL2200235 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/05Import · Class 1 BMS-986256胶囊 · No verified English nameJXHL2200234 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/05Import · Class 1 注射用替曲朵辛 · No verified English nameJXHL2200226 WEX Pharmaceuticals Inc.; PPC China Corporation Limited
2022/08/05Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201244 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/08/05Generic · Class 3 Ebastine Oral SolutionCYHS2201240 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2022/08/05New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2200362 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/08/05New drug · Class 1 KP104注射液 · No verified English nameCXSL2200361 Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/08/05New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2200360 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2022/08/05New drug · Class 1 IMG-007注射液 · No verified English nameCXSL2200359 Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/08/05New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2200358 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/08/05New drug · Class 1.4 EV71-CA16二价手足口病灭活疫苗(人二倍体细胞) · No verified English nameCXSL2200357 Ai Mei Kang Huai Biopharmaceutical (Jiangsu) Co., Ltd. romanized
2022/08/05New drug · Class 1 IN10018片 · No verified English nameCXHL2200571 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/08/05New drug · Class 1 IN10018片 · No verified English nameCXHL2200570 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/08/05New drug · Class 1 LP-108片 · No verified English nameCXHL2200569 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2022/08/05New drug · Class 1 LP-108片 · No verified English nameCXHL2200568 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2022/08/05New drug · Class 1 HBW-3210胶囊 · No verified English nameCXHL2200563 Chengdu Hai Bo Wei Pharma Co., Ltd. romanized
2022/08/04Import · Class 3.1 Faricimab注射液 · No verified English nameJXSS2200030 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd
2022/08/04Import · Class 1 ARV-471(PF-07850327 )片 · No verified English nameJXHL2200233 Pfizer Inc; Pfizer Investment CO. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200232 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200231 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200230 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200229 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200228 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Import · Class 1 Mezigdomide(CC-92480)胶囊 · No verified English nameJXHL2200227 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/04Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHS2201239 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2022/08/04Generic · Class 3 Minoxidil LinimentCYHS2201231 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/04New drug · Class 1.1 九味化斑丸 · No verified English nameCXZL2200035 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2022/08/04New drug · Class 1 注射用TQB2934 · No verified English nameCXSL2200356 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/08/04New drug · Class 1.4 十七价重组人乳头瘤病毒疫苗(汉逊酵母) · No verified English nameCXSL2200355 Chongqing Bo Wei Bai Tai Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized
2022/08/04New drug · Class 1 BA2101注射液 · No verified English nameCXSL2200354 Shandong Bo An Bio Technology Co., Ltd. romanized

50 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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