YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 1 December 2023 and 7 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 52 drug names.

2023/12/01 – 2023/12/07

Period
2023/12/01 to 2023/12/07, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
1

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

290filings, 65 of them generic

By application type

Application typeFilings
Supplement131
Generic65
New drug53
Import23
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug197
Therapeutic biologic52
TCM33
Biologic7
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
2阿普米司特片 · No verified English name313
3Diprophylline Injection227
4甘油磷酸钠注射液 · No verified English name227
5Agomelatine Tablets228
6Folic acid injection211
7Potassium Chloride Granules214
8Loxoprofen Sodium Patches2130
9Dopamine Hydrochloride Injection213
10Trazodone Hydrochloride Tablets215

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized10100
2medac Gesellschaft für klinische Spezialpr?parate mbH810
3Janssen Research & Development LLC750
4Novo Nordisk A/S720
5Hainan Ying Da Run Ze Pharma Co., Ltd. romanized660
6AstraZeneca AB630
7Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized545
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
10Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized420

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

89 this week

AcceptedDrugApplicants
2023/12/07Import · Class 3.1 莫妥珠单抗注射液 · No verified English nameJXSS2300087 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2023/12/07Import · Class 3.1 莫妥珠单抗注射液 · No verified English nameJXSS2300086 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2023/12/07Generic · Class 3 Foscarnet Sodium InjectionCYHS2303384 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/07Generic · Class 3 Diprophylline InjectionCYHS2303383 Ze Tian (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2023/12/07Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303382 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2023/12/07Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303381 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2023/12/07Generic · Class 3 Diprophylline InjectionCYHS2303378 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/07Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2303377 Hubei Jin Yao Pharma Co., Ltd. romanized
2023/12/07Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2303373 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2023/12/07Generic · Class 3 Methocarbamol InjectionCYHS2303372 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/12/07New drug · Class 1 司普奇拜单抗注射液 · No verified English nameCXSS2300090 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/07New drug · Class 1 AHT-102注射液 · No verified English nameCXSL2300845 Guangxi Lu Gang Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/07New drug · Class 1 LP-003 注射液 · No verified English nameCXSL2300844 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/12/07New drug · Class 1 GCK-01细胞注射液 · No verified English nameCXSL2300843 Shanghai Jing Shan Bio Technology Co., Ltd. romanized
2023/12/07New drug · Class 1 HP537片 · No verified English nameCXHL2301352 Hai Chuang Pharma Co., Ltd. romanized
2023/12/07New drug · Class 1 HP537片 · No verified English nameCXHL2301351 Hai Chuang Pharma Co., Ltd. romanized
2023/12/07New drug · Class 1 HSK39775片 · No verified English nameCXHL2301350 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/12/07New drug · Class 1 HSK39775片 · No verified English nameCXHL2301349 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/12/07New drug · Class 2.2 LPC-023口溶膜 · No verified English nameCXHL2301348 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/06Import · Class 1 Litifilimab (BIIB059) · No verified English nameJXSL2300217 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2023/12/06Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2303360 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized
2023/12/06Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2303359 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized
2023/12/06Generic · Class 3 Potassium Chloride GranulesCYHS2303358 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2023/12/06Generic · Class 3 Potassium Chloride GranulesCYHS2303357 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2023/12/06Generic · Class 3 Folic acid injectionCYHS2303354 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/06Generic · Class 3 Folic acid injectionCYHS2303353 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/06New drug · Class 1 TNM002注射液 · No verified English nameCXSS2300092 Zhuhai Tai Nuo Mai Bo Pharmaceutical Co., Ltd. romanized
2023/12/06New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2300091 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/12/06New drug · Class 1 HB0034注射液 · No verified English nameCXSL2300841 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/06New drug · Class 1 HB0017注射液 · No verified English nameCXSL2300840 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized

59 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.