YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 354 drug applications between 17 January 2026 and 23 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 47 drug names.

2026/01/17 – 2026/01/23

Period
2026/01/17 to 2026/01/23, 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
354
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
87

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

354filings, 64 of them generic

By application type

Application typeFilings
Supplement164
New drug73
Generic64
Import38
Unspecified11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug206
Therapeutic biologic84
TCM59
Biologic3
In vitro diagnostic reagent1
Prophylactic biologic1

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

47 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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1210
2Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized970
3Kashima Plant Eisai Co. Ltd.660
4Pfizer Inc.630
5Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
6Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized510
7Qilu Pharmaceutical Co., Ltd.441
8F. Hoffmann-La Roche Ltd430
9Amgen Inc.420
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

126 this week

AcceptedDrugApplicants
2026/01/23Import · Class 1 PF-08634404 · No verified English nameJXSL2600024 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 PF-08634404 · No verified English nameJXSL2600023 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 Bleximenib片 · No verified English nameJXHL2600029 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 Bleximenib片 · No verified English nameJXHL2600028 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 HTT227片 · No verified English nameJXHL2600027 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/23Generic · Class 3 Piracetam InjectionCYHS2600266 Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2026/01/23Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600259 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2026/01/23Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600258 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2026/01/23New drug · Class 1.1 丹元糖痹软膏 · No verified English nameCXZL2600012 Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2026/01/23New drug · Class 1.1 十味安神颗粒 · No verified English nameCXZL2600011 Hebei Ping An Health Group Co., Ltd. romanized
2026/01/23New drug · Class 1 注射用GFS784 · No verified English nameCXSL2600124 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/01/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600123 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/01/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600122 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/01/23New drug · Class 1 D-2570片 · No verified English nameCXHL2600111 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2026/01/23New drug · Class 1 RP903片 · No verified English nameCXHL2600110 Jun Shi Run Jia (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/01/23New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2600109 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/01/23New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2600108 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/01/23New drug · Class 1 ETD-001凝胶 · No verified English nameCXHL2600107 Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2026/01/23New drug · Class 1 ETD-001凝胶 · No verified English nameCXHL2600106 Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2026/01/23New drug · Class 1 ETD-001凝胶 · No verified English nameCXHL2600105 Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2026/01/23New drug · Class 1 BC-006注射液 · No verified English nameCXHL2600104 Bei Si Ke (Shanghai) Bio Technology Co., Ltd. romanized
2026/01/22Import · Class 2.2 马塔西单抗注射液 · No verified English nameJXSS2600005 Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd.
2026/01/22Import · Class 2.4 LOU064片 · No verified English nameJXHL2600026 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/22Import · Class 2.4 LOU064片 · No verified English nameJXHL2600025 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/22Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600256 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2026/01/22Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600255 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2026/01/22Generic · Class 3 Nimodipine Oral SolutionCYHS2600251 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/01/22Generic · Class 3 Nimodipine Oral SolutionCYHS2600250 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/01/22New drug · Class 1.1 参灵颗粒 · No verified English nameCXZL2600010 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1.2 障复康胶囊 · No verified English nameCXZL2600009 Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized

96 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.