YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 332 drug applications between 10 August 2024 and 16 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 69 drug names.

2024/08/10 – 2024/08/16

Period
2024/08/10 to 2024/08/16, 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
332
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
3

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

332filings, 98 of them generic

By application type

Application typeFilings
Supplement145
Generic98
New drug63
Import17
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug228
TCM54
Therapeutic biologic41
Prophylactic biologic7
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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ketorolac Tromethamine Injection424
2甲磺酸多沙唑嗪片 · No verified English name310
3Labetalol Hydrochloride Injection314
4Epalrestat Tablets221
5Pranoprofen Eye Drops227
6Bisoprolol Fumarate and Amlodipine Besylate Tablets229
7Eperisone Hydrochloride Tablets228
8依伏卡塞片 · No verified English name219
9Vonoprazan Fumarate Tablets2160
10Brexpiprazole Tablets2131

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

201 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Shanxi Hua Kang Pharma Co., Ltd. romanized640
3Novartis Pharma AG620
4Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized550
5Takeda Manufacturing Austria AG520
6Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized440
7Janssen Research & Development LLC420
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized410
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410

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

123 this week

AcceptedDrugApplicants
2024/08/16Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2400067 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/08/16Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSS2400066 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2024/08/16Import · Class 2.4 Axitinib TabletsJXHS2400055 Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2024/08/16Import · Class 2.4 Axitinib TabletsJXHS2400054 Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2024/08/16Import · Class 1 KFA115 · No verified English nameJXHL2400206 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115 · No verified English nameJXHL2400205 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115 · No verified English nameJXHL2400204 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 KFA115 · No verified English nameJXHL2400203 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 HRO761 · No verified English nameJXHL2400202 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Import · Class 1 HRO761 · No verified English nameJXHL2400201 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/08/16Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2402675 Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized
2024/08/16Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2402674 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/08/16Generic · Class 3 Etoposide InjectionCYHS2402672 Hainan Brilliant Pharmaceutical Co., Ltd.
2024/08/16Generic · Class 3 Asenapine Maleate Sublingual TabletsCYHS2402669 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/08/16Generic · Class 3 Asenapine Maleate Sublingual TabletsCYHS2402668 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/08/16Generic · Class 3 Nitroglycerin InjectionCYHS2402667 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2024/08/16Generic · Class 3 Nitroglycerin InjectionCYHS2402666 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 SHR-2173注射液 · No verified English nameCXSL2400546 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/16New drug · Class 1 重组抗BDCA2人源化单克隆抗体注射液 · No verified English nameCXSL2400545 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/08/16New drug · Class 1 重组抗BDCA2人源化单克隆抗体注射液 · No verified English nameCXSL2400544 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/08/16New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400076 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400075 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 TQB3909片 · No verified English nameCXHL2400847 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 TQB3909片 · No verified English nameCXHL2400846 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 TLL-041缓释片 · No verified English nameCXHL2400845 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 TLL-041缓释片 · No verified English nameCXHL2400844 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2024/08/16New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2400843 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/08/16New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2400842 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/08/16New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2400841 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/08/16New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2400840 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

93 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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