YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 371 drug applications between 15 October 2026 and 21 October 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 44, covering 34 drug names.

2026/10/15 – 2026/10/21

Period
2026/10/15 to 2026/10/21, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
371
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
339

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

371filings, 44 of them generic

By application type

Application typeFilings
Supplement198
New drug85
Generic44
Import25
Import re-registration10
Unspecified9

By drug type

Drug typeFilings
Chemical drug186
TCM114
Therapeutic biologic64
Prophylactic biologic4
Biologic2
In vitro diagnostic reagent1

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets3127
2Acetylcysteine Oral Solution2111
3Tacrolimus Sustained-release Capsules216
4环硅酸锆钠散 · No verified English name2112
5Arginine and Ibuprofen Granules2111
6Bimatoprost Eye Drops213
7Dapagliflozin Tablets2184
8Zolpidem tartrate extended-release tablets214
9Avanafil Tablets212
10四季抗病毒合剂 · No verified English name111

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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1340
2Hunan Dong Jian Pharma Co., Ltd. romanized880
3Janssen-Cilag International NV640
4Shanxi Huang He Zhong Yao Co., Ltd. romanized550
5AbbVie Inc.530
6Medice Arzneimittel Pütter GmbH & Co. KG510
7Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized440
8Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized430
9Shandong Xin Shi Dai Pharma Co., Ltd. romanized430
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420

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

120 this week

AcceptedDrugApplicants
2026/10/21Import · Class 1 SAR447998注射用浓溶液 · No verified English nameJXSL2600280 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/10/21Import · Class 1 SAR447998注射用浓溶液 · No verified English nameJXSL2600279 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/10/21Import · Class 1 ABBV-253注射用粉末 · No verified English nameJXSL2600278 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/21Import · Class 1 ALXN1720注射液 · No verified English nameJXSL2600277 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/21Import · Class 2.4 Momelotinib 片 · No verified English nameJXHL2600460 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/10/21Import · Class 2.4 Momelotinib 片 · No verified English nameJXHL2600459 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/10/21Import · Class 2.4 Momelotinib 片 · No verified English nameJXHL2600458 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/10/21Import · Class 1 DDY391片 · No verified English nameJXHL2600457 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/10/21Import · Class 1 Ferric Bepectate IV Injection · No verified English nameJXHL2600456 AFT Pharmaceuticals Ltd
2026/10/21Import · Class 1 Ferric Bepectate IV Injection · No verified English nameJXHL2600455 AFT Pharmaceuticals Ltd
2026/10/21Import · Class 1 Ferric Bepectate IV Injection · No verified English nameJXHL2600454 AFT Pharmaceuticals Ltd
2026/10/21Generic · Class 3 Acetylcysteine Oral SolutionCYHS2602584 Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized
2026/10/21Generic · Class 3 Acetylcysteine Oral SolutionCYHS2602583 Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized
2026/10/21Generic · Class 3 Zolpidem tartrate extended-release tabletsCYHL2600119 Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2026/10/21Generic · Class 3 Zolpidem tartrate extended-release tabletsCYHL2600118 Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2026/10/21New drug · Class 1.1 健骨关节颗粒 · No verified English nameCXZL2600106 Beijing Yi Ling Pharma Co., Ltd. romanized
2026/10/21New drug · Class 1.1 JSBCPZ001颗粒 · No verified English nameCXZL2600105 Beijing Chuang Li Ke Chuang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/10/21New drug · Class 1.1 达瓦依鲁克蜜丸 · No verified English nameCXZL2600104 Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Yi Hospital (Xinjiang Wei Wu Er Zi Zhi Qu Di Er Ren Min Hospital) romanized
2026/10/21New drug · Class 2.3 保济口服液 · No verified English nameCXZL2600103 Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized
2026/10/21New drug · Class 1.1 金莲咽扁颗粒 · No verified English nameCXZL2600102 Guangzhou Bo Ji Xin Yao Lin Chuang Research Center Co., Ltd. romanized
2026/10/21New drug · Class 2.2 注射用伦康依隆妥单抗 · No verified English nameCXSS2600166 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Name not romanized
2026/10/21New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSL2601161 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/10/21New drug · Class 1 注射用DB-1311 · No verified English nameCXSL2601160 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/10/21New drug · Class 1 SHR-3045注射液 · No verified English nameCXSL2601159 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/10/21New drug · Class 1 注射用SIM0500 · No verified English nameCXSL2601158 Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized
2026/10/21New drug · Class 1 注射用SIM0500 · No verified English nameCXSL2601157 Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized
2026/10/21New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2601156 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/10/21New drug · Class 1 注射用CGB3002 · No verified English nameCXSL2601155 Jia Jin Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/10/21New drug · Class 1 SHR-2614眼内注射液 · No verified English nameCXSL2601154 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/10/21New drug · Class 1 SHR-2614眼内注射液 · No verified English nameCXSL2601153 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized

90 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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