YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 22 December 2021 and 28 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 56 drug names.

2021/12/22 – 2021/12/28

Period
2021/12/22 to 2021/12/28, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
56
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

367filings, 82 of them generic

By application type

Application typeFilings
Supplement155
Generic82
New drug82
Import21
Unspecified15
Import re-registration12

By drug type

Drug typeFilings
Chemical drug254
Therapeutic biologic77
TCM26
In vitro diagnostic reagent4
Biologic4
Prophylactic biologic2

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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Febuxostat Tablets5312
2Sitagliptin Phosphate Tablets422
3Esmolol Hydrochloride Injection223
4Sodium Valproate Concentrated Solution for Injection210
5Elagolix Tablets212
6Ozagrel Sodium Injection213
7Olanzapine Orally Disintegrating Tablets210
8Torsemide Injection211
9Tegafur,Gimeracil and Oteracil Potassium Capsules210
10Sacubitril Valsartan Sodium Tablets2170

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Shuang He Pharma Co., Ltd. romanized1230
2Boehringer Ingelheim International GmbH720
3Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized660
4Novo Nordisk A/S620
5Shanghai Ying Li Pharma Co., Ltd. romanized620
6Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized620
7Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized440
8Pfizer Europe MA EEIG430
9Haerbin Tian Mei Pharma Co., Ltd. romanized430
10Yi Chang Ren Fu Pharma Co., Ltd. romanized432

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

131 this week

AcceptedDrugApplicants
2021/12/28Import · Class 1 SVN53-67/M57-KLH肽疫苗 · No verified English nameJXSL2101152 MimiVax LLC; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2021/12/28Import · Class 1 Lotilaner滴眼液 · No verified English nameJXHL2101288 Lianbio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2021/12/28Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2102305 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2021/12/28Generic · Class 3 Aminocaproic Acid InjectionCYHS2102296 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/12/28Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102292 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/12/28Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102291 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/12/28Generic · Class 3 Multiple Vitamins InjectionCYHS2102282 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2021/12/28New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101525 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 IBI322 · No verified English nameCXSL2101524 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/12/28New drug · Class 1 RB0026注射液 · No verified English nameCXSL2101523 Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 注射用JS107 · No verified English nameCXSL2101522 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101521 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/12/28New drug · Class 2.1 人碱性成纤维细胞生长因子凝胶 · No verified English nameCXSL2101519 Yao Gu (Wen Zhou) Technology Development Co., Ltd. romanized
2021/12/28New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101518 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/12/28New drug · Class 1 注射用ATG-101 · No verified English nameCXSL2101517 De Qi (Hangzhou) Bio Co., Ltd. romanized
2021/12/28New drug · Class 1 PM8001注射液 · No verified English nameCXSL2101515 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/12/28New drug · Class 1 KD6001注射液 · No verified English nameCXSL2101514 Shanghai Kang Dai Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Sai Jin Biopharmaceuticals Co., Ltd. romanized
2021/12/28New drug · Class 1 SI-B003双特异性抗体注射液 · No verified English nameCXSL2101510 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/12/28New drug · Class 1 甲磺酸奥瑞替尼片 · No verified English nameCXHS2101058 Nanjing Sheng He Pharma Co., Ltd. romanized
2021/12/28New drug · Class 2.1 右美托咪定透皮贴剂(Ⅱ) · No verified English nameCXHL2101834 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/28New drug · Class 1 HS-10380片 · No verified English nameCXHL2101829 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 HS-10380片 · No verified English nameCXHL2101828 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 HS-10380片 · No verified English nameCXHL2101827 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 2.4 青蒿琥酯片 · No verified English nameCXHL2101826 Gui Lin Nan Yao Co., Ltd. romanized
2021/12/28New drug · Class 1 ICP-488片 · No verified English nameCXHL2101823 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 ICP-488片 · No verified English nameCXHL2101822 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 ICP-488片 · No verified English nameCXHL2101821 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 YY001片 · No verified English nameCXHL2101820 Shanghai Yu Yao Bio Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 YY001片 · No verified English nameCXHL2101819 Shanghai Yu Yao Bio Technology Co., Ltd. romanized
2021/12/28New drug · Class 1 ST-1839肠溶片 · No verified English nameCXHL2101817 Beijing Sai Te Ming Qiang Pharmaceuticals Technology Co., Ltd. romanized

101 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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