YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 116 drug applications between 5 October 2021 and 11 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 16 drug names.

2021/10/05 – 2021/10/11

Period
2021/10/05 to 2021/10/11, 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
116
Drugs with new generic filings (by drug name, de-duplicated)
16
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

116filings, 20 of them generic

By application type

Application typeFilings
Supplement65
Generic20
New drug16
Unspecified8
Import6
Import re-registration1

By drug type

Drug typeFilings
Chemical drug76
Therapeutic biologic22
TCM14
Biologic4

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

16 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Parecoxib Sodium for Injection322
2Ornidazole Injection210
3Cyclophosphamide Capsules212
4Lidocaine Cataplasms117
5Salbutamol Sulfate Inhalation Solution112
6Diquafosol Sodium Eye Drops115
7Olmesartan Medoxomil Tablets111
8Sildenafil Citrate Tablets1112
9氧 · No verified English name1115
10Amlodipine Besylate and Atorvastatin Calcium Tablets112

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

80 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized410
2Hangzhou Minsheng Pharmaceutical Co., Ltd330
3Jiangxi Di Kang Pharma Co., Ltd. romanized330
4Janssen-Cilag International NV320
5Cheng De Xin Ai Min Pharmaceutical Co., Ltd. romanized320
6Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized310
7Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized310
8Zhejiang Guo Jing Pharma Co., Ltd. romanized310
9Zhejiang Dou Bang Pharma Co., Ltd. romanized310
10Shenzhen Li Jian Pharma Co., Ltd. romanized310

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

28 this week

AcceptedDrugApplicants
2021/10/11Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2101830 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/10/11Generic · Class 3 Ornidazole InjectionCYHS2101828 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/10/11Generic · Class 3 Ornidazole InjectionCYHS2101827 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/10/11Generic · Class 3 Lidocaine CataplasmsCYHS2101824 Hainan Hui Yuan Tang Pharma Co., Ltd. romanized
2021/10/11New drug · Class 1 QLF31911注射液 · No verified English nameCXSL2101354 Qilu Pharmaceutical Co., Ltd.
2021/10/11New drug · Class 1 人源TH-SC01细胞注射液 · No verified English nameCXSL2101353 Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101543 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101542 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101541 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 AN4005片 · No verified English nameCXHL2101540 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/11New drug · Class 1 AN4005片 · No verified English nameCXHL2101539 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/11New drug · Class 2.2 复方对乙酰氨基酚缓释片 · No verified English nameCXHL2101530 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101196 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101195 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 注射用 WCK5222 · No verified English nameJXHL2101191 Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.
2021/10/09Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2101826 Wu Hu Yang Yan Pharmaceutical Co., Ltd. romanized
2021/10/09New drug · Class 1.1 九味疏风平喘颗粒 · No verified English nameCXZL2101028 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2021/10/09New drug · Class 1 LBL-019注射液 · No verified English nameCXSL2101348 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2021/10/09New drug · Class 1 TST005注射液 · No verified English nameCXSL2101346 Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/10/09New drug · Class 1 SHR-1314注射液 · No verified English nameCXSL2101345 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/10/08Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSL2101116 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/10/08Import · Class 1 BI-1206 · No verified English nameJXSL2101115 BioInvent International AB; CASI Pharmaceuticals (China) Co. Ltd.
2021/10/08Generic · Class 3 Cyclophosphamide CapsulesCYHS2101811 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/08Generic · Class 3 Cyclophosphamide CapsulesCYHS2101810 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/08New drug · Class 1 LY01019注射液 · No verified English nameCXSL2101351 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/10/08New drug · Class 1 SIM1811-03注射液 · No verified English nameCXSL2101350 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2021/10/08New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101347 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2021/10/08New drug · Class 2.2 醋酸阿比特龙软胶囊 · No verified English nameCXHL2101528 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized

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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