YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 287 drug applications between 15 January 2023 and 21 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 53 drug names.

2023/01/15 – 2023/01/21

Period
2023/01/15 to 2023/01/21, 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
287
Drugs with new generic filings (by drug name, de-duplicated)
53
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

287filings, 78 of them generic

By application type

Application typeFilings
Supplement133
Generic78
New drug50
Import12
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug214
TCM38
Therapeutic biologic35

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Quetiapine Fumarate Tablets310
3Betamethasone Sodium Phosphate Injection225
4Diquafosol Sodium Eye Drops225
5Levosimendan Injection221
6Pentoxifylline Injection223
7Telmisartan and Hydrochlorothiazide Tablets222
8Regorafenib Tablets223
9Ganirelix Injection221
10Perindopril and Indapamide Tablets213

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

164 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized24231
2Qilu Pharmaceutical Co., Ltd.665
3MUNDIPHARMA GmbH610
4Kang Zhi Pharma Co., Ltd. romanized550
5Pfizer Inc.520
6Jiangxi Shimei Pharmaceutical Co., Ltd525
7Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized443
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
9Qilu Pharmaceutical (Hainan) Co., Ltd424
10Grand Medical Pty Ltd.330

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

79 this week

AcceptedDrugApplicants
2023/01/21New drug · Class 1 CT041自体CAR T细胞注射液 · No verified English nameCXSL2300059 Shanghai Ke Ji Pharmaceutical Co., Ltd. romanized
2023/01/20Import · Class 1 VSA003注射液 · No verified English nameJXHL2300013 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/20Import · Class 1 Milvexian片 · No verified English nameJXHL2300012 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/01/20Generic · Class 3 Pentoxifylline InjectionCYHS2300207 Ping Guang Pharmaceutical Co., Ltd. romanized
2023/01/20Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300203 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/01/20Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2300199 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 2.2; 2.3 HYR0201颗粒 · No verified English nameCXZL2300003 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 注射用SHR-4602 · No verified English nameCXSL2300058 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/01/20New drug · Class 1 注射用AP026 · No verified English nameCXSL2300057 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300016 Bei Da Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300015 Bei Da Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2300110 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300109 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300108 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300107 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300103 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300102 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300101 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300100 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300099 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/01/19Import · Class 1 VSA001注射液 · No verified English nameJXHL2300011 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/19Import · Class 1 BRM421 滴眼液 · No verified English nameJXHL2300010 BRIM Biotechnology Inc.; Grandpharma (China) Co. Ltd.
2023/01/19Generic · Class 3 Ornidazole InjectionCYHS2300196 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/01/19Generic · Class 3 Ornidazole InjectionCYHS2300195 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/01/19Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2300192 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300190 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 醋酸维持液(含葡萄糖) · No verified English nameCYHS2300189 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 Peramivir InjectionCYHS2300186 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2023/01/19Generic · Class 3 Nimodipine Oral SolutionCYHS2300185 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2023/01/19Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300183 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized

49 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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