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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 199 drug applications between 25 March 2022 and 31 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 28 drug names.

2022/03/25 – 2022/03/31

Period
2022/03/25 to 2022/03/31, 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
199
Drugs with new generic filings (by drug name, de-duplicated)
28
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

199filings, 34 of them generic

By application type

Application typeFilings
Supplement105
New drug35
Generic34
Import16
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug145
Therapeutic biologic33
TCM20
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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Riociguat Tablets314
2氧(液态) · No verified English name2213
3Tranexamic Acid Injection2111
4Sodium Thiosulfate Injection213
5Dapagliflozin Tablets2184
6Sodium Valproate Oral Solution111
7Carboprost Tromethamine Injection112
8Carbazochrome Sodium Sulfonate Injection111
9Salbutamol Sulfate Inhalation Solution112
10噻托溴铵吸入粉雾剂 · No verified English name112

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

132 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

53 this week

AcceptedDrugApplicants
2022/03/31Import · Class 2.2 HL242吸入气雾剂 · No verified English nameJXHL2200079 HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd.
2022/03/31Import · Class 2.2 HL242吸入气雾剂 · No verified English nameJXHL2200078 HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd.
2022/03/31Import · Class 2.2 HL242吸入气雾剂 · No verified English nameJXHL2200077 HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd.
2022/03/31Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2200513 Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized
2022/03/31Generic · Class 3 Tranexamic Acid InjectionCYHS2200509 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2022/03/31Generic · Class 3 Tranexamic Acid InjectionCYHS2200508 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2022/03/31New drug · Class 1 自体多抗原特异性细胞毒性T淋巴细胞注射液 · No verified English nameCXSL2200153 Shenzhen Yi Shi Kang Ning Bio Technology Co., Ltd. romanized
2022/03/31New drug · Class 1 SH010注射液 · No verified English nameCXSL2200149 Nanjing Sheng He Pharma Co., Ltd. romanized
2022/03/31New drug · Class 1 注射用ZKLJ02 · No verified English nameCXHL2200207 Yunnan Zhong Ke Long Jin Bio Technology Co., Ltd. romanized
2022/03/31New drug · Class 2.3 注射用BH006 · No verified English nameCXHL2200206 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2022/03/30Import · Class 2.2 肾上腺素鼻喷雾剂 · No verified English nameJXHL2200076 ARS Pharmaceuticals Inc.; Pediatrix Therapeutics (Shanghai) Co. Ltd
2022/03/30Import · Class 2.2 肾上腺素鼻喷雾剂 · No verified English nameJXHL2200075 ARS Pharmaceuticals Inc.; Pediatrix Therapeutics (Shanghai) Co. Ltd
2022/03/30Generic · Class 3 Sodium Thiosulfate InjectionCYHS2200503 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/03/30Generic · Class 3 Sodium Thiosulfate InjectionCYHS2200502 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/03/30New drug · Class 1 AK104注射液 · No verified English nameCXSL2200134 Kang Fang Pharma Co., Ltd. romanized
2022/03/30New drug · Class 2.3 注射用H889A · No verified English nameCXHL2200205 Hu Zhou Hui Zhong Ji Shi Bio Technology Co., Ltd. romanized
2022/03/30New drug · Class 2.3 注射用H889A · No verified English nameCXHL2200204 Hu Zhou Hui Zhong Ji Shi Bio Technology Co., Ltd. romanized
2022/03/30New drug · Class 1 WJ13404片 · No verified English nameCXHL2200203 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/30New drug · Class 1 WJ13404片 · No verified English nameCXHL2200202 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/30New drug · Class 1 Ceralasertib薄膜包衣片 · No verified English nameCXHL2200201 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2022/03/30New drug · Class 1 Ceralasertib薄膜包衣片 · No verified English nameCXHL2200200 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2022/03/29Generic · Class 3 Tirofiban Hydrochloride InjectionCYHS2200496 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/03/29New drug · Class 1.1 清达颗粒 · No verified English nameCXZL2200016 Fujian Zhong Pharmaceuticals University romanized
2022/03/29New drug · Class 1 GR1901注射液 · No verified English nameCXSL2200152 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/03/29New drug · Class 1 JS006注射液 · No verified English nameCXSL2200151 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/03/29New drug · Class 1 注射用GB263T · No verified English nameCXSL2200150 Jia He Bio Pharma Co., Ltd. romanized
2022/03/29New drug · Class 1 SHR4640片 · No verified English nameCXHL2200199 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/03/29New drug · Class 1 SHR4640片 · No verified English nameCXHL2200198 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/03/29New drug · Class 1 SHR4640片 · No verified English nameCXHL2200197 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/03/29New drug · Class 1 SHR4640片 · No verified English nameCXHL2200196 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

23 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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