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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 471 drug applications between 11 January 2023 and 17 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 75 drug names.

2023/01/11 – 2023/01/17

Period
2023/01/11 to 2023/01/17, 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
471
Drugs with new generic filings (by drug name, de-duplicated)
75
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

471filings, 99 of them generic

By application type

Application typeFilings
Supplement246
Generic99
New drug77
Import21
Import re-registration15
Unspecified13

By drug type

Drug typeFilings
Chemical drug322
TCM80
Therapeutic biologic62
Prophylactic biologic4
Biologic3

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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops4116
2Sodium Hyaluronate Eye Drops4130
3Nifedipine Controlled-release Tablets317
4Diquafosol Sodium Eye Drops225
5Dobutamine Hydrochloride Injection223
6Ganirelix Injection221
7Fluvoxamine Maleate Tablets220
8Clindamycin Injection214
9Ibuprofen Injection218
10Lafutidine Tablets212

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

256 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Luo Bang Pharma Co., Ltd. romanized25190
2Ping Guang Pharmaceutical Co., Ltd. romanized14140
3Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized12120
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD940
5Zhengzhou Shi Bao Long Pharma Co., Ltd. romanized880
6Suzhou Hong Sen Pharma Co., Ltd. romanized828
7Ji Chuan Pharma Group Co., Ltd. romanized632
8Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized630
9Sichuan Pharmaceutical Formulations Co., Ltd. romanized610
10Shandong Run Ze Pharmaceutical Co., Ltd. romanized610

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

129 this week

AcceptedDrugApplicants
2023/01/17Import · Class 2.2 司库奇尤单抗注射液 · No verified English nameJXSL2300025 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2023/01/17Generic · Class 3 Emtricitabine, Rilpivirine, and Tenofovir Alafenamide TabletsCYHS2300165 Qilu Pharmaceutical Co., Ltd.
2023/01/17Generic · Class 3 Ibuprofen InjectionCYHS2300163 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2023/01/17Generic · Class 3 Ibuprofen InjectionCYHS2300162 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2023/01/17Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHS2300157 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/01/17Generic · Class 3 Pentoxifylline InjectionCYHS2300156 Shandong Qidu Pharmaceutical Co., Ltd.
2023/01/17Generic · Class 3 Lafutidine TabletsCYHS2300155 Ji Chuan Pharma Group Co., Ltd. romanized
2023/01/17Generic · Class 3 Lafutidine TabletsCYHS2300154 Ji Chuan Pharma Group Co., Ltd. romanized
2023/01/17Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300148 Jilin Sheng Dou Bang Pharma Co., Ltd. romanized
2023/01/17Generic · Class 3 Dienogest TabletsCYHL2300007 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/01/17New drug · Class 1.1 异功散颗粒 · No verified English nameCXZL2300002 Shen Wei Pharma Group Co., Ltd. romanized
2023/01/17New drug · Class 1 重组人内皮抑素腺病毒注射液 · No verified English nameCXSL2300046 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2023/01/17New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2300044 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/01/17New drug · Class 1 注射用BC3195 · No verified English nameCXSL2300043 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2023/01/17New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2300042 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2023/01/17New drug · Class 1 IMC002注射液 · No verified English nameCXSL2300041 Suzhou Yi Mu Feng Bio Technology Co., Ltd. romanized
2023/01/17New drug · Class 1 APL-1401胶囊 · No verified English nameCXHL2300087 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/01/17New drug · Class 1 APL-1401 胶囊 · No verified English nameCXHL2300086 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/01/16New drug · Class 2.2 BCM345口溶膜 · No verified English nameCXHL2300085 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2023/01/16New drug · Class 1 TUL01101片 · No verified English nameCXHL2300084 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2023/01/16New drug · Class 1 TUL01101片 · No verified English nameCXHL2300083 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2023/01/15New drug · Class 1 FCN-159片 · No verified English nameCXHL2300082 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/01/15New drug · Class 1 FCN-159片 · No verified English nameCXHL2300081 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/01/14Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300143 Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized
2023/01/14Generic · Class 3 Clindamycin InjectionCYHS2300140 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/01/14Generic · Class 3 Clindamycin InjectionCYHS2300139 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/01/14Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHL2300006 Fujian Rui Tai Lai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/14Generic · Class 3 Desvenlafaxine Extended-release TabletsCYHL2300005 Fujian Rui Tai Lai Pharmaceuticals Technology Co., Ltd. romanized
2023/01/14New drug · Class 1 注射用JYB1907 · No verified English nameCXSL2300040 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2023/01/14New drug · Class 1 苹果酸司曲替尼胶囊 · No verified English nameCXHL2300080 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

99 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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