YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 266 drug applications between 20 February 2026 and 26 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.

2026/02/20 – 2026/02/26

Period
2026/02/20 to 2026/02/26, 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
266
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
95

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

266filings, 60 of them generic

By application type

Application typeFilings
Supplement110
New drug65
Generic60
Import17
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug179
Therapeutic biologic50
TCM33
Prophylactic biologic4

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

46 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

152 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized750
2Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
3Takeda Development Center Americas Inc.620
4Luo Yang Shun Shi Pharma Co., Ltd. romanized550
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized540
6Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized530
7Sichuan Pharmaceutical Formulations Co., Ltd. romanized520
8The Wellcome Foundation Limited510
9Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized510
10Guizhou Rui He Pharmaceutical 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

103 this week

AcceptedDrugApplicants
2026/02/26Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2600057 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2026/02/26Import · Class 1 BMS-986528注射液 · No verified English nameJXSL2600056 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/02/26Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2600551 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/02/26Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2600549 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2026/02/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600548 Anhui Jia He Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600547 Anhui Jia He Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/26Generic · Class 3 Minoxidil LinimentCYHS2600537 Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2026/02/26Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600533 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2026/02/26Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600531 Yan Tai Lu Yin Pharma Co., Ltd. romanized
2026/02/26Generic · Class 3 Bumetanide InjectionCYHS2600530 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/02/26Generic · Class 3 Bumetanide InjectionCYHS2600529 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/02/26New drug · Class 3.1 宣郁通经汤颗粒 · No verified English nameCXZS2600014 Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized
2026/02/26New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600031 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/02/26New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSS2600030 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2026/02/26New drug · Class 1 UX-GIP001注射液 · No verified English nameCXSL2600259 Shanghai Yue Sai Bio Technology Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2600256 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/02/26New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600255 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600254 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2600253 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600252 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600251 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2600250 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2600249 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600248 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 注射用FH-006 · No verified English nameCXSL2600247 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 MY008211A片 · No verified English nameCXHS2600033 Wuhan Qi Rui Pharma Co., Ltd. romanized
2026/02/26New drug · Class 1 AHB-171注射液 · No verified English nameCXHL2600240 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
2026/02/26New drug · Class 1 H001片 · No verified English nameCXHL2600236 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2026/02/26New drug · Class 1 QLS7305注射液 · No verified English nameCXHL2600235 Qilu Pharmaceutical Co., Ltd.
2026/02/26New drug · Class 1 QLS7305注射液 · No verified English nameCXHL2600234 Qilu Pharmaceutical Co., Ltd.

73 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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