YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 22 January 2026 and 28 January 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 49, covering 34 drug names.

2026/01/22 – 2026/01/28

Period
2026/01/22 to 2026/01/28, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
67

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

309filings, 49 of them generic

By application type

Application typeFilings
Supplement164
New drug75
Generic49
Import11
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug186
TCM59
Therapeutic biologic59
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

34 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

183 companies with new acceptances; top 10 listed

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

102 this week

AcceptedDrugApplicants
2026/01/28Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2600291 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2026/01/28Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2600290 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/01/28New drug · Class 1 BG-A3004注射液 · No verified English nameCXSL2600146 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/01/28New drug · Class 1 RRG001眼内注射液 · No verified English nameCXSL2600141 Shanghai Ding Xin Ji Yin Technology Co., Ltd. romanized
2026/01/28New drug · Class 1 BNT324 · No verified English nameCXSL2600140 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/01/28New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2600139 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/01/28New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2600138 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/01/28New drug · Class 2.1; 2.2 伏欣奇拜单抗注射液 · No verified English nameCXSL2600137 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/01/28New drug · Class 2.1; 2.2 伏欣奇拜单抗注射液 · No verified English nameCXSL2600136 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/01/28New drug · Class 1 人溶菌酶滴眼液 · No verified English nameCXSL2600135 Shaanxi Hui Kang Bio Technology Co., Ltd. romanized
2026/01/28New drug · Class 1 HRS-3005片 · No verified English nameCXHL2600131 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/01/28New drug · Class 1 HRS-3005片 · No verified English nameCXHL2600130 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/01/28New drug · Class 2.2 N015鼻喷雾剂 · No verified English nameCXHL2600129 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized
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

72 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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