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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 145 drug applications between 21 December 2022 and 27 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 16 drug names.

2022/12/21 – 2022/12/27

Period
2022/12/21 to 2022/12/27, 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
145
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

145filings, 20 of them generic

By application type

Application typeFilings
Supplement71
Import21
Generic20
New drug18
Unspecified11
Import re-registration4

By drug type

Drug typeFilings
Chemical drug98
Therapeutic biologic36
TCM8
Prophylactic biologic3

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
1Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
2Voriconazole Tablets211
3Iopromide Injection2127
4Propofol Medium And Long Chain Fat Emulsion Injection113
5Tadalafil Tablets1123
6Allopurinol Tablets114
7Salbutamol Sulfate Inhalation Solution112
8Palbociclib Tablets112
9Desonide Cream110
10Formoterol Fumarate Inhalation Solution115

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

88 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized1010
2Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized930
3An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized540
4Idience Co. Ltd.410
5Microlabs330
6CSPC OUYI PHARMACEUTICAL CO., LTD.331
7Amgen Inc.310
8Otsuka Pharmaceutical Co.,Ltd.310
9Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized310
10Shanghai Hai Yan Pharmaceuticals Technology 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

38 this week

AcceptedDrugApplicants
2022/12/27Import · Class 3.3 甘精胰岛素注射液 · No verified English nameJXSS2200043 Eli Lilly Nederland B.V.; Lilly France S.A.S.; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/12/27Import · Class 3.3 甘精胰岛素注射液 · No verified English nameJXSS2200042 Eli Lilly Nederland B.V.; Lilly France S.A.S.; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/12/27Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2202105 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2022/12/27Generic · Class 3 Desonide CreamCYHS2202104 Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2022/12/27Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2202102 Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/12/27Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202101 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/12/27Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202100 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/12/27Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202099 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/12/27New drug · Class 1 注射用SMET12 · No verified English nameCXSL2200618 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2022/12/27New drug · Class 1 HB0025注射液 · No verified English nameCXSL2200617 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2022/12/27New drug · Class 1 注射用重组人白介素22-Fc融合蛋白 · No verified English nameCXSL2200616 Yi Yi Biopharmaceuticals Kai Fa (Shanghai) Co., Ltd. romanized
2022/12/27New drug · Class 1 LP-003 注射液 · No verified English nameCXSL2200615 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/12/27New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200953 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/12/27New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200952 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/12/27New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200951 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/12/26New drug · Class 1.1 苏合颗粒 · No verified English nameCXZL2200055 Chongqing Ju Qi Nuo Mei Pharmaceutical Co., Ltd. romanized; Beijing Zhong Pharmaceuticals University romanized
2022/12/26New drug · Class 2.3 痹克片 · No verified English nameCXZL2200054 Hefei Jin Yue Pharmaceutical Co., Ltd. romanized
2022/12/26New drug · Class 1 YH008注射用冻干粉 · No verified English nameCXSL2200614 Name not romanized
2022/12/26New drug · Class 2.2 BCM347口溶膜 · No verified English nameCXHL2200950 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2022/12/26New drug · Class 1 HRS-5965片 · No verified English nameCXHL2200949 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/12/26New drug · Class 1 HRS-5965片 · No verified English nameCXHL2200948 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/12/24Import · Class 3.1 依库珠单抗注射液 · No verified English nameJXSS2200041 Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd
2022/12/24Import · Class 1 LY3473329片 · No verified English nameJXHL2200351 Eli Lilly and Company
2022/12/24Import · Class 1 LY3473329片 · No verified English nameJXHL2200350 Eli Lilly and Company
2022/12/23Import · Class 1 AMG 451 · No verified English nameJXSL2200211 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/12/23Import · Class 1 AMG 451 · No verified English nameJXSL2200210 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/12/23Import · Class 1 AMG 451 · No verified English nameJXSL2200209 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/12/23Import · Class 1 Cetrelimab 注射液 · No verified English nameJXSL2200208 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/12/23Import · Class 1 Cetrelimab 注射液(皮下注射) · No verified English nameJXSL2200207 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/12/23Import · Class 1 MEDI5752 · No verified English nameJXSL2200206 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

8 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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