YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 469 drug applications between 23 July 2026 and 29 July 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 63, covering 44 drug names.

2026/07/23 – 2026/07/29

Period
2026/07/23 to 2026/07/29, 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
469
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
157

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

469filings, 63 of them generic

By application type

Application typeFilings
Supplement274
New drug79
Generic63
Import29
Unspecified20
Import re-registration4

By drug type

Drug typeFilings
Chemical drug249
TCM146
Therapeutic biologic64
Biologic7
Prophylactic biologic3

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

44 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

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1050
2AstraZeneca AB730
3Name not romanized720
4Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized550
5Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized550
6Novartis Pharma Schweiz AG530
7Changchun Jin Sai Pharma Co., Ltd. romanized520
8Takeda Development Center Americas Inc.510
9Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized440
10Jiangsu Kang Yuan Pharma Co., Ltd. romanized440

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
2026/07/29Import · Class 1 注射用TAK-121 · No verified English nameJXHL2600303 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/07/29Import · Class 1 注射用TAK-121 · No verified English nameJXHL2600302 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/07/29Import · Class 1 注射用TAK-121 · No verified English nameJXHL2600301 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/07/29Import · Class 1 注射用TAK-121 · No verified English nameJXHL2600300 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/07/29Import · Class 1 注射用TAK-121 · No verified English nameJXHL2600299 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/07/29Generic · Class 3 磷酸二氢钠磷酸氢二钠颗粒 · No verified English nameCYHS2601827 Shandong Pu Ji Pharmaceuticals Technology Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized
2026/07/29Generic · Class 3 Mianserin Hydrochloride TabletsCYHS2601820 Jewim Pharmaceutical (Shandong) Co., Ltd.
2026/07/29New drug · Class 1 注射用瑞康芦泽妥塔单抗 · No verified English nameCXSS2600111 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600792 Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600791 Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600790 Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600789 Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600788 Name not romanized
2026/07/29New drug · Class 1 LX111注射液 · No verified English nameCXSL2600787 Name not romanized
2026/07/29New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2600786 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2026/07/29New drug · Class 1 注射用ZK2401 · No verified English nameCXSL2600785 Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized
2026/07/29New drug · Class 1 BGM0504片 · No verified English nameCXHL2600931 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/29New drug · Class 1 BGM0504片 · No verified English nameCXHL2600930 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/29New drug · Class 1 BGM0504片 · No verified English nameCXHL2600929 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2026/07/29New drug · Class 1 JMN-2205片 · No verified English nameCXHL2600928 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/07/29New drug · Class 1 JMN-2205片 · No verified English nameCXHL2600927 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/07/29New drug · Class 1 JMN-2205片 · No verified English nameCXHL2600926 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2026/07/29New drug · Class 2.4 盐酸司美那非片 · No verified English nameCXHL2600925 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/07/29New drug · Class 2.4 盐酸司美那非片 · No verified English nameCXHL2600924 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/07/29New drug · Class 2.4 盐酸司美那非片 · No verified English nameCXHL2600923 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
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

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.

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.