YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 229 drug applications between 11 July 2021 and 17 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 20 drug names.

2021/07/11 – 2021/07/17

Period
2021/07/11 to 2021/07/17, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
20
Accepted this week, now under review
0

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

229filings, 21 of them generic

By application type

Application typeFilings
Supplement136
New drug45
Generic21
Import19
Unspecified7
Import re-registration1

By drug type

Drug typeFilings
Chemical drug165
Therapeutic biologic40
TCM23
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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Epinastine Hydrochloride Granules210
2Sodium Valproate Oral Solution111
3Rivastigmine transdermal system111
4Salbutamol Sulfate Inhalation Solution112
5地氯雷他定口服溶液 · No verified English name1126
6Digoxin Injection113
7奥美拉唑碳酸氢钠干混悬剂(II) · No verified English name110
8Olmesartan Medoxomil and Amlodipine Besylate Tablets112
9Olmesartan Medoxomil Tablets111
10Levetiracetam extended-release tablets110

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

133 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized1360
2Actelion Pharmaceuticals Ltd810
3Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized770
4Novartis Pharma Schweiz AG710
5Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized620
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
7Hefei Li Fang Pharmaceutical Co., Ltd. romanized550
8Bei Da Pharma Co., Ltd. romanized410
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized330
10Guangxi Gu Fang Pharma Co., Ltd. romanized330

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

64 this week

AcceptedDrugApplicants
2021/07/16Import · Class 1 LOXO-305片 · No verified English nameJXHL2101139 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/07/16Import · Class 1 LOXO-305片 · No verified English nameJXHL2101138 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/07/16Import · Class 1 LOXO-305片 · No verified English nameJXHL2101137 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/07/16Import · Class 1 Finerenone TabletsJXHL2101136 Bayer AG; Bayer Healthcare Company Ltd.
2021/07/16Import · Class 1 Finerenone TabletsJXHL2101135 Bayer AG; Bayer Healthcare Company Ltd.
2021/07/16Generic · Class 3 Tranexamic Acid InjectionCYHS2101442 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2021/07/16New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101202 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/07/16New drug · Class 1 恩沃利单抗注射液 · No verified English nameCXSL2101201 Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized
2021/07/16New drug · Class 2.2 BH002注射液 · No verified English nameCXHL2101297 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2021/07/15Import · Class 2.4 硫酸阿托品滴眼液 · No verified English nameJXHL2101133 ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED
2021/07/15Import · Class 2.4 硫酸阿托品滴眼液 · No verified English nameJXHL2101132 ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED
2021/07/15Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101438 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/07/15Generic · Class 3 Digoxin InjectionCYHS2101427 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2021/07/15Generic · Class 3 Levetiracetam extended-release tabletsCYHS2101407 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2021/07/15New drug · Class 1 注射用TJ011133 · No verified English nameCXSL2101200 Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized
2021/07/15New drug · Class 1 SynOV1.1腺病毒注射液 · No verified English nameCXSL2101198 Beijing He Sheng Ji Yin Technology Co., Ltd. romanized
2021/07/15New drug · Class 3.3 LY05008注射液 · No verified English nameCXSL2101197 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/07/15New drug · Class 3.3 LY05008注射液 · No verified English nameCXSL2101196 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/07/15New drug · Class 1 CM355 · No verified English nameCXSL2101185 Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized
2021/07/15New drug · Class 1 注射用HS-20089 · No verified English nameCXSL2101180 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/15New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2101179 Guangzhou Sai Lai La Gan Xi Bao Technology Co., Ltd. romanized
2021/07/15New drug · Class 1 BJRX-R06 胶囊 · No verified English nameCXHL2101296 Beijing Rui Xi Bio Technology Co., Ltd. romanized
2021/07/15New drug · Class 1 BJRX-R06 胶囊 · No verified English nameCXHL2101295 Beijing Rui Xi Bio Technology Co., Ltd. romanized
2021/07/15New drug · Class 2.4 Remimazolam Besylate For InjectionCXHL2101294 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/07/15New drug · Class 1 UP-818-CC注射液 · No verified English nameCXHL2101293 Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized
2021/07/14Import · Class 3.1 那昔妥单抗注射液 · No verified English nameJXSS2101016 Y-mAbs Therapeutics Inc.; Patheon Manufacturing Services LLC; SciClone Pharmaceuticals (China) Co. Ltd.
2021/07/14New drug · Class 3.4 门冬胰岛素30注射液 · No verified English nameCXSS2101012 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2021/07/14New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSS2101011 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2021/07/14New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101195 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/07/14New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2101194 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized

34 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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