YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 490 drug applications between 22 July 2026 and 28 July 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 66, covering 45 drug names.

2026/07/22 – 2026/07/28

Period
2026/07/22 to 2026/07/28, 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
490
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
167

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

490filings, 66 of them generic

By application type

Application typeFilings
Supplement293
New drug76
Generic66
Import32
Unspecified19
Import re-registration4

By drug type

Drug typeFilings
Chemical drug252
TCM149
Therapeutic biologic76
Biologic8
Prophylactic biologic5

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

299 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S2160
2AstraZeneca AB620
3Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized550
4Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized550
5Merck Sharp & Dohme LLC530
6Novartis Pharma Schweiz AG530
7Changchun Jin Sai Pharma Co., Ltd. romanized520
8Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized440
9Hunan Zhong Yi Tai Pharmaceutical Co., Ltd. romanized440
10Kang Pu Pharma 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

118 this week

AcceptedDrugApplicants
2026/07/28Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHL2600298 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/07/28Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHL2600297 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/07/28Import · Class 1 AZD4144薄膜包衣片 · No verified English nameJXHL2600296 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/28Import · Class 1 AZD4144薄膜包衣片 · No verified English nameJXHL2600295 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/28Import · Class 1 Izicopan软胶囊 · No verified English nameJXHL2600294 InflaRx GmbH; KG Pharma Limited
2026/07/28Import · Class 2.2 乌帕替尼口服溶液 · No verified English nameJXHL2600293 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2026/07/28Import · Class 2.2 乌帕替尼口服溶液 · No verified English nameJXHL2600292 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2026/07/28Generic · Class 3 Azilsartan TabletsCYHS2601817 Zhejiang Nord Pharmaceutical Co., Ltd
2026/07/28Generic · Class 3 Minoxidil LinimentCYHS2601811 Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2026/07/28Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHS2601810 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/07/28Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHS2601809 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/07/28Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHS2601808 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/07/28Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2601807 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2026/07/28New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2600039 Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized
2026/07/28New drug · Class 3.1 当归四逆汤颗粒 · No verified English nameCXZS2600038 Guangdong Jing Dian Ming Fang Technology Co., Ltd. romanized; Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized
2026/07/28New drug · Class 1 注射用TJ102 · No verified English nameCXSL2600784 Shanghai Tuo Ji Pharmaceuticals Co., Ltd. romanized
2026/07/28New drug · Class 1 SY001注射液 · No verified English nameCXSL2600783 Sai Yuan Bio Technology (Hangzhou) Co., Ltd. romanized
2026/07/28New drug · Class 1 QLS2312注射液 · No verified English nameCXSL2600782 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/07/28New drug · Class 2.2 注射用BL-B01D1 · No verified English nameCXSL2600781 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/07/28New drug · Class 1 人脐带间充质干细胞Ⅱ型注射液 · No verified English nameCXSL2600780 Zhejiang Wo Wu Gan Xi Bao Technology Co., Ltd. romanized
2026/07/28New drug · Class 2.3 奥美沙坦酯左氨氯地平片 · No verified English nameCXHS2600111 Beijing Foyou Pharma CO.,LTD
2026/07/28New drug · Class 2.3 BN024910F · No verified English nameCXHL2600922 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/07/28New drug · Class 2.2 盐酸环丙沙星吸入粉雾剂 · No verified English nameCXHL2600921 Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized
2026/07/28New drug · Class 1 RF2011 注射液 · No verified English nameCXHL2600920 Rui Fu Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized; Nanjing Hong Di Bio Technology Co., Ltd. romanized
2026/07/28New drug · Class 2.4 Z21204 · No verified English nameCXHL2600919 Beijing Si Li An Pharma Co., Ltd. romanized
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600291 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600290 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600289 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600288 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 RO7568282胶囊 · No verified English nameJXHL2600287 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.

88 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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