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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 284 drug applications between 22 July 2023 and 28 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 48 drug names.

2023/07/22 – 2023/07/28

Period
2023/07/22 to 2023/07/28, 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
284
Drugs with new generic filings (by drug name, de-duplicated)
48
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

284filings, 57 of them generic

By application type

Application typeFilings
Supplement142
Generic57
New drug45
Import30
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug183
Therapeutic biologic54
TCM41
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
2Roxatidine Acetate Hydrochloride For Injection225
3Tacrolimus Sustained-release Capsules216
4Pravastatin Sodium Tablets212
5Carfilzomib For Injection210
6Cefuroxime Sodium for Injection218
7Naloxone Hydrochloride Injection211
8Calcium Gluconate in Sodium Chloride Injection215
9Sodium Valproate Oral Solution111
10Acetylcysteine Injection1153

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

162 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan He Li Xin Jian Pharma Co., Ltd. romanized15140
2Guizhou Tian Di Pharma Co., Ltd. romanized1230
3Bayer AG920
4BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED720
5Sanofi Winthrop Industrie510
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD442
7Changsha Xin Lin Pharmaceutical Co., Ltd. romanized440
8Shaanxi Feng Wu Chen Da Yao Tang Pharmaceutical Factory Co., Ltd. romanized440
9Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized430
10Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized430

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

97 this week

AcceptedDrugApplicants
2023/07/28Import · Class 3.1 奥瑞利珠单抗注射液 · No verified English nameJXSS2300065 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH
2023/07/28Import · Class 3.1 奥瑞利珠单抗注射液 · No verified English nameJXSS2300064 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH
2023/07/28Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300144 Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited
2023/07/28Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300143 Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited
2023/07/28Import · Class 3.1 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300142 Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited
2023/07/28Import · Class 2.4 ABL001片 · No verified English nameJXHL2300179 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/07/28Import · Class 2.4 ABL001片 · No verified English nameJXHL2300178 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/07/28Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2302024 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/07/28Generic · Class 3 Diprophylline InjectionCYHS2302021 Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Jin Feng Pharmaceutical Co., Ltd. romanized
2023/07/28Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2302016 Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized
2023/07/28Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2302014 Jiangsu Chen Pai Pharma Group Co., Ltd. romanized; Jiangsu Han Chen Pharma Co., Ltd. romanized
2023/07/28Generic · Class 3 Salbutamol Sulfate injectionCYHS2302013 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/28Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2302012 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2023/07/28Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2302011 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2023/07/28New drug · Class 1 注射用CMD011 · No verified English nameCXSL2300524 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2023/07/28New drug · Class 1 CEFFE001注射剂 · No verified English nameCXSL2300523 Shanghai Sa Mei Xi Bao Technology Co., Ltd. romanized
2023/07/28New drug · Class 2.2 阿哌沙班口崩片 · No verified English nameCXHL2300826 Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized
2023/07/28New drug · Class 1 MBT-1608片 · No verified English nameCXHL2300825 Beijing SL Pharmaceutical Co., Ltd.
2023/07/28New drug · Class 1 BW-20805 注射液 · No verified English nameCXHL2300824 Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized
2023/07/28New drug · Class 2.2 JW2202吸入粉雾剂 · No verified English nameCXHL2300823 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/07/28New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2300822 Le Pu Pharma Co., Ltd. romanized
2023/07/28New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2300821 Le Pu Pharma Co., Ltd. romanized
2023/07/27Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2300141 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/27Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2300140 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/07/27Generic · Class 3 Ursodeoxycholic acid oral suspensionCYHS2302006 Name not romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized
2023/07/27New drug · Class 1 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300522 An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/27New drug · Class 1 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300521 An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/27New drug · Class 1 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300520 An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/27New drug · Class 1 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300519 An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized
2023/07/27New drug · Class 3.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300518 Jiangsu Rui Ke Bio Technology Co., Ltd. romanized; Beijing An Bai Sheng Bio Technology Co., Ltd. romanized

67 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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