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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 338 drug applications between 21 January 2026 and 27 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 42 drug names.

2026/01/21 – 2026/01/27

Period
2026/01/21 to 2026/01/27, 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
338
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
80

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

338filings, 57 of them generic

By application type

Application typeFilings
Supplement166
New drug78
Generic57
Import20
Unspecified11
Import re-registration6

By drug type

Drug typeFilings
Chemical drug215
Therapeutic biologic67
TCM51
In vitro diagnostic reagent2
Biologic2
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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1醋酸艾司利卡西平片 · No verified English name414
2Perindopril tert-Butylamine Tablets215
3复方氨基酸注射液(17AA-Ⅲ) · No verified English name212
4Nimodipine Oral Solution214
5Budesonide Nasal Spray213
6Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation2112
7Phenylephrine Hydrochloride Injection215
8Bromhexine Hydrochloride Oral Solution2122
9Ziprasidone Hydrochloride Capsules219
10Minoxidil Liniment2152

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized970
2Kashima Plant Eisai Co. Ltd.660
3Pfizer Inc.630
4Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized630
5Novo Nordisk A/S620
6Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
7Novartis Pharma AG540
8Sanofi Winthrop Industrie430
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420

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

116 this week

AcceptedDrugApplicants
2026/01/27Import · Class 2.2 N-803 · No verified English nameJXSL2600025 ImmunityBio Inc.; Hangzhou Tigermed Consulting Co. Ltd
2026/01/27Generic · Class 3 Minoxidil LinimentCYHS2600286 Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2026/01/27Generic · Class 3 Minoxidil LinimentCYHS2600285 Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2026/01/27Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2600284 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Sichuan De Feng Pharma Co., Ltd. romanized
2026/01/27New drug · Class 1.1 XKZ2305颗粒 · No verified English nameCXZL2600013 Lian Cheng Xun Kang (Zhuhai Heng Qin) Pharma Co., Ltd. romanized
2026/01/27New drug · Class 1 AZD0305 · No verified English nameCXSL2600134 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2026/01/27New drug · Class 1 注射用SSGJ-612 · No verified English nameCXSL2600133 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/01/27New drug · Class 1 注射用SSGJ-705 · No verified English nameCXSL2600132 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/01/27New drug · Class 1 BNT326 · No verified English nameCXSL2600131 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/01/27New drug · Class 1 BNT327 · No verified English nameCXSL2600130 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/01/27New drug · Class 1 BBT001皮下注射液 · No verified English nameCXSL2600128 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/27New drug · Class 1 BBT001皮下注射液 · No verified English nameCXSL2600127 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/27New drug · Class 2.2; 2.4 LP注射液 · No verified English nameCXHL2600128 Shenzhen Peng Jia Pharmaceuticals Technology Co., Ltd. romanized; Shenzhen Bo Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/01/27New drug · Class 1 苯磺酸CG-0255胶囊 · No verified English nameCXHL2600127 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized
2026/01/27New drug · Class 2.4 JP-1366片 · No verified English nameCXHL2600126 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2026/01/27New drug · Class 1 TQB3205胶囊 · No verified English nameCXHL2600125 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/01/27New drug · Class 1 TQB3205胶囊 · No verified English nameCXHL2600124 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/01/26Generic · Class 3 Lansoprazole For InjectionCYHS2600280 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2026/01/26Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2600276 Shandong Qidu Pharmaceutical Co., Ltd.
2026/01/26New drug · Class 1 BG-A3004注射液 · No verified English nameCXSL2600129 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/01/26New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2600126 Shandong Lan Yi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2600125 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/01/26New drug · Class 1 BCR-0003片 · No verified English nameCXHL2600123 Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 1 BCR-0003片 · No verified English nameCXHL2600122 Zhejiang Zhong Shen Innovation Pharmaceuticals Technology Co., Ltd. romanized
2026/01/26New drug · Class 1 DC561043片 · No verified English nameCXHL2600121 Zhongguo Ke College Shanghai Drug Research Institute romanized; Lin Gang Guo Jia Laboratory romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600270 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600269 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600268 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24Generic · Class 3 醋酸艾司利卡西平片 · No verified English nameCYHS2600267 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2026/01/24New drug · Class 1 RSS0393乳胶 · No verified English nameCXHL2600120 Rui Shi Biopharmaceuticals Co., Ltd. romanized

86 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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