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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 246 drug applications between 18 August 2021 and 24 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 28 drug names.

2021/08/18 – 2021/08/24

Period
2021/08/18 to 2021/08/24, 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
246
Drugs with new generic filings (by drug name, de-duplicated)
28
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

246filings, 34 of them generic

By application type

Application typeFilings
Supplement148
New drug35
Generic34
Unspecified15
Import10
Import re-registration4

By drug type

Drug typeFilings
Chemical drug163
TCM48
Therapeutic biologic28
Biologic4
Prophylactic biologic3

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Perampanel Tablets412
2硫酸特布他林雾化吸入用溶液 · No verified English name221
3Voglibose Tablets210
4Perindopril tert-Butylamine Tablets215
5Rivaroxaban Tablets113
6Ipratropium Bromide Inhalation Solution112
7Ambroxol Hydrochloride Solution For Inhalation1110
8Celecoxib Capsules115
9Doxofylline Injection115
10Levofloxacin Tablets117

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

131 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Run Zhong Pharma Co., Ltd. romanized16150
2GUERBET1310
3Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
4Hubei Mei Si Chuang Pharma Co., Ltd. romanized550
5Qin Huang Dao Da En Pharma Co., Ltd. romanized550
6Shaanxi Bao Ling Kang Pharmaceutical Co., Ltd. romanized540
7Merck Sharp & Dohme Corp.510
8Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized440
9Hainan Si Da Pharmaceutical Co., Ltd. romanized442
10Yuan He Sheng (Jilin) Pharma Co., Ltd. romanized440

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

47 this week

AcceptedDrugApplicants
2021/08/24Import · Class 1 DS-1062a · No verified English nameJXSL2101101 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/08/24Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2101630 Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized
2021/08/24New drug · Class 1 IM21嵌合抗原受体T细胞注射液(IM21 CAR-T细胞注射液) · No verified English nameCXSL2101281 Beijing Yi Miao Shen Zhou Pharmaceuticals Technology Co., Ltd. romanized
2021/08/24New drug · Class 1 重组抗金黄色葡萄球菌毒素人源化单克隆抗体注射液 · No verified English nameCXSL2101277 Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/08/24New drug · Class 2.2 复方葡萄糖酸钙颗粒 · No verified English nameCXHS2101035 Xinjiang Te Feng Pharma Co., Ltd. romanized
2021/08/24New drug · Class 2.4 妥布霉素雾化吸入溶液 · No verified English nameCXHL2101429 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2021/08/24New drug · Class 2.4 Irinotecan Liposome injectionCXHL2101428 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/08/24New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101412 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/24New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101411 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/24New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101410 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/23Import · Class 3.1 雷莫西尤单抗注射液 · No verified English nameJXSS2101018 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/08/23Import · Class 3.1 雷莫西尤单抗注射液 · No verified English nameJXSS2101017 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/08/23Import · Class 1 BI655130注射液 · No verified English nameJXSL2101098 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/23Import · Class 2.4 ATG-010片 · No verified English nameJXHL2101168 Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd.
2021/08/23New drug · Class 3.2 口服五价重配轮状病毒减毒活疫苗(Vero细胞) · No verified English nameCXSL2101279 Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized; Beijing Min Hai Bio Technology Co., Ltd. romanized
2021/08/23New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101275 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101270 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/23New drug · Class 1 ATG-008片 · No verified English nameCXHL2101427 Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/08/23New drug · Class 1 ATG-008片 · No verified English nameCXHL2101426 Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101425 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101424 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2101423 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/20Generic · Class 3 Calcium Gluconate InjectionCYHS2101610 Zhejiang Rui Bang Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/08/20Generic · Class 3 Trelagliptin Succinate TabletsCYHS2101572 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/08/20New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2101021 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/08/20New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101276 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/20New drug · Class 2.2 丁苯酞注射液 · No verified English nameCXHL2101422 Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized
2021/08/20New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101421 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/08/20New drug · Class 1 BEBT-209胶囊 · No verified English nameCXHL2101420 Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized
2021/08/19Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2101099 MedImmune LLC; AstraZeneca Investment (China) Co. Limited

17 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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