YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 16 October 2026 and 22 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 45 drug names.

2026/10/16 – 2026/10/22

Period
2026/10/16 to 2026/10/22, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
321

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

347filings, 56 of them generic

By application type

Application typeFilings
Supplement188
New drug66
Generic56
Import24
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug186
TCM101
Therapeutic biologic55
Biologic2
Prophylactic 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

45 drugs with new generic filings; top 10 listed

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

228 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
5Medice Arzneimittel Pütter GmbH & Co. KG510
6Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized440
7Shandong Xin Shi Dai Pharma Co., Ltd. romanized430
8AbbVie Inc.420
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized410

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

Entered review this week
0
Left the under-review list this week
167

Of these, NMPA published approval-document delivery for 137 (including 130 supplemental applications, not counted as new marketing approvals) and notification delivery for 7; the outcome of the other 23 is to be checked.

Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized43
2AstraZeneca AB42
3Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized41
4Zhejiang Guo Jing Pharma Co., Ltd. romanized41
5Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized33
6Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized33
7Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized32
8Mylan Pharmaceuticals Inc.22
9Shanghai Lei Yun Shang Pharma Co., Ltd. romanized22
10Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized22

Most filings entering review, by company

No filings entered review this 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

104 this week

AcceptedDrugApplicants
2026/10/22Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2602600 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2026/10/22Generic · Class 3 艾地骨化醇片 · No verified English nameCYHS2602592 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2026/10/22Generic · Class 3 Calcium Gluconate InjectionCYHS2602590 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/10/22Generic · Class 3 lorazepam injectionCYHL2600120 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2026/10/22New drug · Class 2.5 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2601165 Guangzhou Bai Yun Shan Bio Zhi Pin Co., Ltd. romanized
2026/10/22New drug · Class 1 NK010(冻存制剂)细胞注射液 · No verified English nameCXSL2601164 Shanghai En Kai Xi Bao Technology Co., Ltd. romanized
2026/10/22New drug · Class 1 JK06注射液 · No verified English nameCXSL2601163 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/10/22New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2601162 Tianjin He Chuang Bio Technology Co., Ltd. romanized
2026/10/22New drug · Class 1 CG-0416片 · No verified English nameCXHL2601316 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized
2026/10/22New drug · Class 1 CG-0416片 · No verified English nameCXHL2601315 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized
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

74 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.