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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 469 drug applications between 2 August 2026 and 8 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 60 drug names.

2026/08/02 – 2026/08/08

Period
2026/08/02 to 2026/08/08, 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
469
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
212

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

469filings, 84 of them generic

By application type

Application typeFilings
Supplement257
Generic84
New drug82
Import36
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug207
TCM176
Therapeutic biologic83
Prophylactic biologic2
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1替尔泊肽注射液 · No verified English name4122
2Edaravone and Dexborneol Concentrated Solution for Injection3334
3Ambroxol Hydrochloride Solution For Inhalation3110
4Ixazomib Citrate Capsules317
5鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name316
6Fluvastatin Sodium Extended Release Tablets226
7Ipratropium Bromide Inhalation Solution212
8地氯雷他定口服溶液 · No verified English name2126
9Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
10Cyclophosphamide for Injection213

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

263 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized18170
2Eli Lilly and Company1120
3Topfond Pharmaceutical Co., Ltd.660
4Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized660
5Bayer Inc.610
6Gilead Sciences Inc.610
7Li Zhu Group Li Min Pharmaceutical Factory romanized610
8Hubei Dong Xin Pharma Co., Ltd. romanized550
9Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550
10AbbVie Inc.530

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

144 this week

AcceptedDrugApplicants
2026/08/07Import · Class 3.1 尼塞韦单抗注射液 · No verified English nameJXSS2600072 Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd.
2026/08/07Import · Class 3.1 尼塞韦单抗注射液 · No verified English nameJXSS2600071 Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600331 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600330 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600329 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/07Generic · Class 3 Ferrous Succinate TabletsCYHS2601935 Anhui Zheng Yao Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/08/07Generic · Class 3 Acetaminophen InjectionCYHS2601934 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/08/07Generic · Class 3 Gatifloxacin Eye DropsCYHS2601932 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized
2026/08/07Generic · Class 3 Ropinirole Hydrochloride TabletsCYHS2601930 Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized
2026/08/07New drug · Class 3.1 当归六黄汤颗粒 · No verified English nameCXZS2600045 Shen Wei Pharma Group Co., Ltd. romanized
2026/08/07New drug · Class 3.1 厚朴温中汤颗粒 · No verified English nameCXZS2600044 Shen Wei Pharma Group Co., Ltd. romanized
2026/08/07New drug · Class 3.1 化肝煎颗粒 · No verified English nameCXZS2600043 Shen Wei Pharma Group Co., Ltd. romanized
2026/08/07New drug · Class 3.3 人生长激素注射液 · No verified English nameCXSS2600121 Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized
2026/08/07New drug · Class 3.3 人生长激素注射液 · No verified English nameCXSS2600120 Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized
2026/08/07New drug · Class 1 SSGJ-718注射液 · No verified English nameCXSL2600847 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2026/08/07New drug · Class 1 SSGJ-718注射液 · No verified English nameCXSL2600846 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2026/08/07New drug · Class 1 IMC002注射液 · No verified English nameCXSL2600845 Suzhou Yi Mu Feng Biopharmaceutical Co., Ltd. romanized; Shenzhen Yi Mu Feng Bio Technology Co., Ltd. romanized
2026/08/07New drug · Class 1.2 鼻喷重组呼吸道合胞病毒疫苗(黑猩猩腺病毒载体) · No verified English nameCXSL2600844 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2026/08/07New drug · Class 1 注射用MBS314 · No verified English nameCXSL2600843 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2026/08/07New drug · Class 1.1 冻干二价人类偏肺病毒mRNA疫苗 · No verified English nameCXSL2600842 Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized
2026/08/07New drug · Class 1 AP301胶囊 · No verified English nameCXHS2600115 Li Bang Pharmaceutical (Yang Zhou) Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
2026/08/07New drug · Class 1 S01D片 · No verified English nameCXHL2600976 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/08/07New drug · Class 1 S01D片 · No verified English nameCXHL2600975 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/08/06Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600328 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/06Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600327 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/06Import · Class 1 Edecesertib 片 · No verified English nameJXHL2600326 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/08/06Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2601919 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2026/08/06Generic · Class 3 琥珀酸索利那新口服混悬液 · No verified English nameCYHS2601913 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized
2026/08/06New drug · Class 2.1 万通筋骨巴布膏 · No verified English nameCXZS2600042 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2026/08/06New drug · Class 1.1 YJZ11031颗粒 · No verified English nameCXZL2600070 Beijing Dong Fang Yun Jia Pharma Co., Ltd. romanized

114 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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