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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 115 drug applications between 12 December 2022 and 18 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 14, covering 12 drug names.

2022/12/12 – 2022/12/18

Period
2022/12/12 to 2022/12/18, 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
115
Drugs with new generic filings (by drug name, de-duplicated)
12
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

115filings, 14 of them generic

By application type

Application typeFilings
Supplement69
Generic14
New drug14
Import re-registration9
Import6
Unspecified3

By drug type

Drug typeFilings
Chemical drug89
TCM16
Therapeutic biologic9
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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops215
2Urapidil Hydrochloride Injection216
3Calcipotriol Ointment115
4Letermovir Injection116
5Flupentixol and Melitracen Tablets114
6氧(液态) · No verified English name1113
7Sacubitril Valsartan Sodium Tablets1170
8Roxatidine Acetate Hydrochloride For Injection115
9Daptomycin for Injection111
10甲苯磺酸卢美哌隆胶囊 · 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

56 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized1090
2Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized990
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized870
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
5Fresenius Kabi AB510
6Medice Arzneimittel Pütter GmbH & Co.KG510
7KOBAYASHI Pharmaceutical Co. Ltd.410
8Jiangxi Hao Ran Biopharmaceutical Co., Ltd. romanized410
9Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized330
10Ling Ke Pharma (Hangzhou) 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

17 this week

AcceptedDrugApplicants
2022/12/17Import · Class 1 TQB2223注射液 · No verified English nameJXSL2200205 CLARUSUN PHARMACEUTICAL CORP.; Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
2022/12/17Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2200113 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/12/17New drug · Class 1 自分泌PD1抗体靶向间皮素嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200605 Shanghai Xi Bao Zhi Liao Group Drug Technology Co., Ltd. romanized
2022/12/17New drug · Class 1 VC005凝胶 · No verified English nameCXHL2200943 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2022/12/17New drug · Class 1 VC005凝胶 · No verified English nameCXHL2200942 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2022/12/17New drug · Class 1 VC005凝胶 · No verified English nameCXHL2200941 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2022/12/16New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSL2200604 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2022/12/16New drug · Class 3.4 静注人免疫球蛋白(pH4) · No verified English nameCXSL2200603 Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200940 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200939 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200938 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 2.2 氟尿嘧啶植入剂 · No verified English nameCXHL2200937 Hefei Ji An Pharmaceuticals Research Co., Ltd. romanized
2022/12/13Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2202066 Shuang He Pharma (Hainan) Co., Ltd. romanized
2022/12/13New drug · Class 1 赫基仑赛注射液(暂定) · No verified English nameCXSS2200093 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2022/12/13New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2200092 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/12/13New drug · Class 2.2 注射用A型肉毒毒素 · No verified English nameCXSL2200602 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2022/12/13New drug · Class 2.2 注射用A型肉毒毒素 · No verified English nameCXSL2200601 Lanzhou Bio Technology Kai Fa 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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