YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 536 drug applications between 7 October 2023 and 13 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 136, covering 101 drug names.

2023/10/07 – 2023/10/13

Period
2023/10/07 to 2023/10/13, 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
536
Drugs with new generic filings (by drug name, de-duplicated)
101
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

536filings, 136 of them generic

By application type

Application typeFilings
Supplement238
Generic136
New drug105
Import26
Import re-registration20
Unspecified10
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug388
TCM70
Therapeutic biologic70
Prophylactic biologic8

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

101 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Edoxaban Tosilate Tablets629
2Diquafosol Sodium Eye Drops445
3Lactulose Oral Solution4334
4Famotidine Injection438
5Nicorandil for Injection321
6Minoxidil Liniment3252
7盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
8Betamethasone Sodium Phosphate Injection225
9Compound Ipratropium Bromide Solution For Inhalation224
10Phenylephrine Hydrochloride Injection225

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

304 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

177 this week

AcceptedDrugApplicants
2023/10/13Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2300181 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/10/13Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2300180 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/10/13Import · Class 3.1 重组B群脑膜炎球菌多组分吸附疫苗 · No verified English nameJXSL2300179 GSK Vaccines S.r.l.
2023/10/13Import · Class 2.4 Ritlecitinib胶囊 · No verified English nameJXHL2300254 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/10/13Import · Class 2.4 Ritlecitinib胶囊 · No verified English nameJXHL2300253 Pfizer Inc.; Pfizer Investment Co. Ltd.
2023/10/13Import · Class 1 LOU064片 · No verified English nameJXHL2300252 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/13Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2302753 Yu Song Yuan Pharma Co., Ltd. romanized
2023/10/13Generic · Class 3 Butorphanol Tartrate InjectionCYHS2302752 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/10/13Generic · Class 3 Butorphanol Tartrate InjectionCYHS2302751 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/10/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302746 Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2023/10/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302745 Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2023/10/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302744 Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2023/10/13Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2302743 Jiangxi Ma Ying Long Mei Kang Pharma Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2023/10/13Generic · Class 3 Diprophylline InjectionCYHS2302739 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/10/13Generic · Class 3 Famotidine InjectionCYHS2302736 Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2023/10/13Generic · Class 3 Famotidine InjectionCYHS2302735 Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2023/10/13Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2302734 Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/10/13Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2302733 Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/10/13Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302732 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/10/13Generic · Class 3 Relugolix TabletsCYHL2300130 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/10/13Generic · Class 3 伏环孢素软胶囊 · No verified English nameCYHL2300129 Qilu Pharmaceutical Co., Ltd.
2023/10/13New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2300086 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2023/10/13New drug · Class 1 ZX2010注射液 · No verified English nameCXSL2300697 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2023/10/13New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2300696 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/10/13New drug · Class 1 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2300695 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/10/13New drug · Class 1 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2300694 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/10/13New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300693 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/10/13New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2300692 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/10/13New drug · Class 1 JMT601注射液 · No verified English nameCXSL2300691 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2023/10/13New drug · Class 2.1 AK1012吸入用溶液 · No verified English nameCXSL2300690 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized

147 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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