YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 30 November 2023 and 6 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 57 drug names.

2023/11/30 – 2023/12/06

Period
2023/11/30 to 2023/12/06, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
57
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

301filings, 71 of them generic

By application type

Application typeFilings
Supplement129
Generic71
New drug59
Import23
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug212
Therapeutic biologic44
TCM38
Biologic7

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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name3126
2盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
3阿普米司特片 · No verified English name313
4甘油磷酸钠注射液 · No verified English name227
5Risperidone Tablets210
6Folic acid injection211
7布洛芬混悬滴剂 · No verified English name210
8Potassium Chloride Granules214
9Loxoprofen Sodium Patches2130
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

188 companies with new acceptances; top 10 listed

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

96 this week

AcceptedDrugApplicants
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
2023/12/06New drug · Class 1 XMVA09注射液 · No verified English nameCXSL2300839 Hefei Xing Mou Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHS2300110 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/06New drug · Class 2.4 顺铂胶束注射液 · No verified English nameCXHL2301347 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/12/06New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301346 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301345 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301344 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2301343 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 注射用HLN601脂质体 · No verified English nameCXHL2301342 Hong Liang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized; Yan Tai Drug Research Institute romanized
2023/12/06New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2301341 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2301340 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2023/12/06New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2301339 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2023/12/05Import · Class 1 SAR443765注射液 · No verified English nameJXSL2300216 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. LTD
2023/12/05Import · Class 1 Eplontersen注射液 · No verified English nameJXHL2300301 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/05Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303346 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/12/05Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2303344 Fujian Tian Quan Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/12/05Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2303343 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2023/12/05Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303339 Suzhou Hong Sen Pharma Co., Ltd. romanized
2023/12/05Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303338 Suzhou Hong Sen Pharma Co., Ltd. romanized
2023/12/05Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303337 Suzhou Hong Sen Pharma Co., Ltd. romanized

66 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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