YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 192 drug applications between 13 July 2021 and 19 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 19 drug names.

2021/07/13 – 2021/07/19

Period
2021/07/13 to 2021/07/19, 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
192
Drugs with new generic filings (by drug name, de-duplicated)
19
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

192filings, 21 of them generic

By application type

Application typeFilings
Supplement105
New drug40
Generic21
Import13
Unspecified10
Import re-registration3

By drug type

Drug typeFilings
Chemical drug128
Therapeutic biologic38
TCM21
Biologic4
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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Epinastine Hydrochloride Granules210
2Ropivacaine hydrochloride injection215
3Sodium Valproate Oral Solution111
4Rivastigmine transdermal system111
5Salbutamol Sulfate Inhalation Solution112
6Digoxin Injection113
7奥美拉唑碳酸氢钠干混悬剂(II) · No verified English name110
8Olmesartan Medoxomil Tablets111
9Levetiracetam extended-release tablets110
10Sildenafil Citrate Tablets1112

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

121 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hefei Li Fang Pharmaceutical Co., Ltd. romanized10100
2Actelion Pharmaceuticals Ltd810
3Novartis Pharma Schweiz AG710
4Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized620
5Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized535
6Shandong Lv Ye Pharmaceutical Co., Ltd. romanized410
7Bei Da Pharma Co., Ltd. romanized410
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized320
9Eli Lilly and Company310
10Loxo Oncology Inc.310

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

57 this week

AcceptedDrugApplicants
2021/07/19Generic · Class 3 Levobupivacaine Hydrochloride InjectionCYHS2101449 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 2.3 滋肾育胎丸 · No verified English nameCXZL2101019 Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized
2021/07/19New drug · Class 1 重组抗VEGFR2全人源单克隆抗体注射液 · No verified English nameCXSL2101203 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized
2021/07/19New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101191 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 注射用RC118 · No verified English nameCXSL2101189 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2021/07/19New drug · Class 2.2 依达拉奉舌下片 · No verified English nameCXHS2101030 Nanjing Bai Xin Yu Pharmaceuticals Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101302 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101301 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101300 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2021/07/19New drug · Class 1 LPM3770164缓释片 · No verified English nameCXHL2101299 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
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

27 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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