YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 521 drug applications between 30 July 2026 and 5 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 57 drug names.

2026/07/30 – 2026/08/05

Period
2026/07/30 to 2026/08/05, 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
521
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
206

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

521filings, 84 of them generic

By application type

Application typeFilings
Supplement280
New drug98
Generic84
Import38
Unspecified12
Import re-registration9

By drug type

Drug typeFilings
Chemical drug248
TCM180
Therapeutic biologic89
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name4226
2Dapagliflozin Tablets4284
3Nafamostat Mesilate for Injection3238
4Ambroxol Hydrochloride Solution For Inhalation3110
5Ixazomib Citrate Capsules317
6Edaravone and Dexborneol Concentrated Solution for Injection2234
7Fluvastatin Sodium Extended Release Tablets226
8盐酸氮?斯汀鼻喷雾剂 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.227
9Ipratropium Bromide Inhalation Solution212
10Dotinurad Tablets2155

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

290 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized18170
2Eli Lilly and Company1120
3AbbVie Inc.960
4Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized660
5Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized650
6Liaoning Min Kang Pharmaceutical Co., Ltd. romanized620
7Li Zhu Group Li Min Pharmaceutical Factory romanized610
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
9Shandong Hong Ji Tang Pharmaceutical Group Co., Ltd. romanized530
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD523

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

161 this week

AcceptedDrugApplicants
2026/08/05Import · Class 1 JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600188 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/08/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600187 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/08/05Import · Class 1 Pasritamig注射液 · No verified English nameJXSL2600186 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/08/05Import · Class 1 DDY391片 · No verified English nameJXHL2600325 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/05Import · Class 1 DDY391片 · No verified English nameJXHL2600324 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/05Import · Class 1 DDY391片 · No verified English nameJXHL2600323 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/05Generic · Class 3 Pregabalin Extended release TabletsCYHS2601907 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2026/08/05Generic · Class 3 Amoxicillin CapsulesCYHS2601906 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2026/08/05Generic · Class 3 Amoxicillin CapsulesCYHS2601905 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2026/08/05Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2601901 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/08/05Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2601900 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/08/05Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2601899 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/08/05Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHL2600086 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized
2026/08/05New drug · Class 3.1 当归建中汤颗粒 · No verified English nameCXZS2600041 Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized
2026/08/05New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600836 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 SHR-4849注射液 · No verified English nameCXSL2600835 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 重组人源化抗FXI双特异性抗体注射液 · No verified English nameCXSL2600834 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/08/05New drug · Class 1 注射用NW001 · No verified English nameCXSL2600833 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Xin Yu Bio Technology Co., Ltd. romanized
2026/08/05New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2600832 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2600831 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 SYS6043 · No verified English nameCXSL2600830 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/08/05New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2600829 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600828 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/05New drug · Class 1 注射用GEN1184 · No verified English nameCXSL2600827 Jin Mai An Bo Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/05New drug · Class 1 GZC8072片 · No verified English nameCXSL2600826 Gan Li Pharma Shandong Co., Ltd. romanized
2026/08/05New drug · Class 1 GZC8072片 · No verified English nameCXSL2600825 Gan Li Pharma Shandong Co., Ltd. romanized
2026/08/05New drug · Class 1 GZC8072片 · No verified English nameCXSL2600824 Gan Li Pharma Shandong Co., Ltd. romanized
2026/08/05New drug · Class 1 GZC8072片 · No verified English nameCXSL2600823 Gan Li Pharma Shandong Co., Ltd. romanized
2026/08/05New drug · Class 1 IBI3002 · No verified English nameCXSL2600822 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/05New drug · Class 1 ES502注射液 · No verified English nameCXSL2600821 Shanghai Ling Shi Zhi Yuan Bio Technology Co., Ltd. romanized

131 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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