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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 138 drug applications between 3 May 2022 and 9 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 14 drug names.

2022/05/03 – 2022/05/09

Period
2022/05/03 to 2022/05/09, 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
138
Drugs with new generic filings (by drug name, de-duplicated)
14
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

138filings, 20 of them generic

By application type

Application typeFilings
Supplement60
New drug37
Generic20
Import17
Unspecified2
Import re-registration2

By drug type

Drug typeFilings
Chemical drug88
Therapeutic biologic28
TCM18
Prophylactic biologic4

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

14 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1奥氮平盐酸氟西汀胶囊 · No verified English name510
2Amisulpride Injection211
3Moxifloxacin Hydrochloride Eye Drops214
4复方聚乙二醇电解质散(Ⅲ) · No verified English name111
5Tinidazole Tablets110
6氧(液态) · No verified English name1113
7Voriconazole for Injection115
8Dexrazoxane for Injection111
9Roxatidine Acetate Hydrochloride For Injection115
10Atomoxetine Hydrochloride Oral Solution110

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

78 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1UNION therapeutics A/S620
2Chengdu Hong Ji Bio Technology Co., Ltd. romanized610
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
4Jiangsu Zhang Tai Pharma Co., Ltd. romanized515
5Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized440
6Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized420
7N.V. Organon410
8Changchun Jin Sai Pharma Co., Ltd. romanized410
9Shandong Han Fang Pharmaceutical Co., Ltd. romanized330
10Pfizer Inc.320

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

62 this week

AcceptedDrugApplicants
2022/05/07Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSL2200055 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/05/07Generic · Class 3 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200710 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2022/05/07Generic · Class 3 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200709 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2022/05/07Generic · Class 3 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200708 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2022/05/07Generic · Class 3 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200707 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2022/05/07Generic · Class 3 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200706 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2022/05/07New drug · Class 1 注射用SKB264 · No verified English nameCXSL2200208 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 注射用重组人源化抗CD47单克隆抗体 · No verified English nameCXSL2200207 Le Pu Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200206 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200205 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200204 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200203 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200202 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 KH631眼用注射液 · No verified English nameCXSL2200201 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 1 注射用SHR-1802 · No verified English nameCXSL2200200 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSL2200199 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSL2200198 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2200197 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 PM8001注射液 · No verified English nameCXSL2200195 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/05/07New drug · Class 1 EG017软膏 · No verified English nameCXHL2200286 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/05/07New drug · Class 1 EG017软膏 · No verified English nameCXHL2200285 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/05/07New drug · Class 1 EG017软膏 · No verified English nameCXHL2200284 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/05/07New drug · Class 1 EG017软膏 · No verified English nameCXHL2200283 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/05/07New drug · Class 1 HRS-7085片 · No verified English nameCXHL2200282 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 HRS-7085片 · No verified English nameCXHL2200281 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 SPN0103-009注射液 · No verified English nameCXHL2200280 Hangzhou Ao Sai Nuo Bio Technology Co., Ltd. romanized
2022/05/07New drug · Class 2.4 Pyrotinib Maleate TabletsCXHL2200279 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 2.4 Pyrotinib Maleate TabletsCXHL2200278 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 HRS-1167片 · No verified English nameCXHL2200277 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/05/07New drug · Class 1 HRS-1167片 · No verified English nameCXHL2200276 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

32 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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