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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 456 drug applications between 8 January 2023 and 14 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 64 drug names.

2023/01/08 – 2023/01/14

Period
2023/01/08 to 2023/01/14, 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
456
Drugs with new generic filings (by drug name, de-duplicated)
64
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

456filings, 85 of them generic

By application type

Application typeFilings
Supplement235
Generic85
New drug80
Import23
Unspecified17
Import re-registration16

By drug type

Drug typeFilings
Chemical drug328
TCM65
Therapeutic biologic54
Prophylactic biologic6
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

64 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
4Dobutamine Hydrochloride Injection223
5Fluvoxamine Maleate Tablets220
6Clindamycin Injection214
7布比卡因脂质体注射液 · No verified English name217
8Metformin Hydrochloride And Empagliflozin Extended Release Tablets2112
9Sacubitril Valsartan Sodium Tablets2170
10Piperacillin Sodium for Injection2116

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

244 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Luo Bang Pharma Co., Ltd. romanized25190
2Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized12120
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD940
4Zhengzhou Shi Bao Long Pharma Co., Ltd. romanized880
5Suzhou Hong Sen Pharma Co., Ltd. romanized828
6Hunan Ke Lun Pharmaceutical Co., Ltd. romanized633
7Sichuan Pharmaceutical Formulations Co., Ltd. romanized610
8Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
9Hangzhou An Dao Pharma Co., Ltd. romanized610
10Janssen Research & Development LLC540

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

130 this week

AcceptedDrugApplicants
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
2023/01/14New drug · Class 1 苹果酸司曲替尼胶囊 · No verified English nameCXHL2300079 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/01/14New drug · Class 1 SVHRSP注射液 · No verified English nameCXHL2300078 Shenyang Wan Jin Pharmaceuticals Technology Co., Ltd. romanized
2023/01/14New drug · Class 1 ARTS-011胶囊 · No verified English nameCXHL2300077 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/01/14New drug · Class 1 ARTS-011胶囊 · No verified English nameCXHL2300076 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/01/14New drug · Class 1 ARTS-011胶囊 · No verified English nameCXHL2300075 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/01/14New drug · Class 1 TQH3910片 · No verified English nameCXHL2300074 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/14New drug · Class 1 TQH3910片 · No verified English nameCXHL2300073 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/14New drug · Class 1 TQB3823片 · No verified English nameCXHL2300072 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/14New drug · Class 1 TQB3823片 · No verified English nameCXHL2300071 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/01/13Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSL2300024 inibio co. ltd.; Beijing Yuzhuo Biotechnology Co. Ltd.
2023/01/13Import · Class 1 MEDI3506注射液 · No verified English nameJXSL2300023 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/13Generic · Class 3 Piperacillin Sodium for InjectionCYHS2300129 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/13Generic · Class 3 Piperacillin Sodium for InjectionCYHS2300128 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/01/13New drug · Class 1 TQB2450注射液 · No verified English nameCXSS2300003 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/01/13New drug · Class 1 KW-027注射液 · No verified English nameCXSL2300038 Beijing Kai Yin Technology Co., Ltd. romanized
2023/01/13New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSL2300037 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2023/01/13New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSL2300036 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2023/01/13New drug · Class 1 GC101腺相关病毒注射液 · No verified English nameCXSL2300035 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2023/01/13New drug · Class 2.2 瑞基奥仑赛注射液 · No verified English nameCXSL2300034 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2023/01/13New drug · Class 3.3 BR201注射液 · No verified English nameCXSL2300033 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized
2023/01/13New drug · Class 1 瑞格列汀二甲双胍片(Ⅱ) · No verified English nameCXHS2300012 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/01/13New drug · Class 1 瑞格列汀二甲双胍片(Ⅰ) · No verified English nameCXHS2300011 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/01/13New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHS2300010 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

100 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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