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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 315 drug applications between 28 June 2022 and 4 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 39 drug names.

2022/06/28 – 2022/07/04

Period
2022/06/28 to 2022/07/04, 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
315
Drugs with new generic filings (by drug name, de-duplicated)
39
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

315filings, 55 of them generic

By application type

Application typeFilings
Supplement130
New drug69
Generic55
Import25
Import re-registration23
Unspecified13

By drug type

Drug typeFilings
Chemical drug243
Therapeutic biologic42
TCM24
Prophylactic biologic5
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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection426
2Tedizolid Phosphate Tablets331
3Levetiracetam extended-release tablets320
4Dapoxetine Hydrochloride Tablets3220
5Norepinephrine Bitartrate Injection229
6Levofloxacin Injection211
7Paliperidone Extend-release Tablets212
8Empagliflozin Tablets2118
9盐酸多奈哌齐口崩片 · No verified English name210
10苯磺酸左氨氯地平片 · No verified English name2145

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer AG660
2Hebei Wu Luo Pharma Co., Ltd. romanized660
3Hubei Kang Wei Yuan Pharma Co., Ltd. romanized660
4Ren He Yi Kang Group Co., Ltd. romanized640
5MUNDIPHARMA GmbH610
6Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized610
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
8Suzhou Ya Sheng Pharma Co., Ltd. romanized420
9Novartis Pharma Schweiz AG410
10Pfizer Europe MA EEIG410

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

96 this week

AcceptedDrugApplicants
2022/07/04Import · Class 1 Cetrelimab · No verified English nameJXSL2200102 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/04Import · Class 1 BN301 · No verified English nameJXSL2200101 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 1 BN301 · No verified English nameJXSL2200100 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200169 AbbVie Inc.
2022/07/04Generic · Class 3 Levetiracetam extended-release tabletsCYHS2200993 Hua Run Sai Ke Pharma Co., Ltd. romanized
2022/07/04Generic · Class 3 Levetiracetam extended-release tabletsCYHS2200992 Hua Run Sai Ke Pharma Co., Ltd. romanized
2022/07/04New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200471 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/07/04New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200470 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/07/04New drug · Class 1 HE009片 · No verified English nameCXHL2200469 Nanchang Hong Yi Pharma Co., Ltd. romanized
2022/07/04New drug · Class 1 HE009片 · No verified English nameCXHL2200468 Nanchang Hong Yi Pharma Co., Ltd. romanized
2022/07/04New drug · Class 1 HE009片 · No verified English nameCXHL2200467 Nanchang Hong Yi Pharma Co., Ltd. romanized
2022/07/04New drug · Class 1 BGB-15025片 · No verified English nameCXHL2200466 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/07/02Import · Class 3.3 贝伐珠单抗注射液 · No verified English nameJXSL2200099 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 3.3 贝伐珠单抗注射液 · No verified English nameJXSL2200098 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200095 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/02New drug · Class 1 BA1106注射液 · No verified English nameCXSL2200307 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 LTC004 · No verified English nameCXSL2200306 Beijing Zhi Dao Bio Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 注射用低分子量岩藻糖化糖胺聚糖钠 · No verified English nameCXSL2200305 Mu Dan Jiang You Bo Pharma Co., Ltd. romanized
2022/07/02New drug · Class 1 靶向GPC3嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200304 Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized
2022/07/02New drug · Class 1 AK119注射液 · No verified English nameCXSL2200296 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200463 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200462 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200461 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200460 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200459 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200458 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 EVER001胶囊 · No verified English nameCXHL2200454 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2022/06/30Generic · Class 3 Nicergoline TabletsCYHS2200980 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200978 Changchun Hai Yue Pharma Co., Ltd. romanized
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200977 Changchun Hai Yue Pharma Co., Ltd. romanized

66 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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