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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 148 drug applications between 22 December 2022 and 28 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 18 drug names.

2022/12/22 – 2022/12/28

Period
2022/12/22 to 2022/12/28, 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
148
Drugs with new generic filings (by drug name, de-duplicated)
18
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

148filings, 27 of them generic

By application type

Application typeFilings
Supplement69
Generic27
Import21
New drug20
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug98
Therapeutic biologic26
TCM18
Biologic3
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection518
2Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
3Voriconazole Tablets211
4Nalbuphine Hydrochloride Injection2111
5Carbocisteine Oral Solution216
6Propofol Medium And Long Chain Fat Emulsion Injection113
7Palbociclib Tablets112
8Desonide Cream110
9Olmesartan Medoxomil Orally Disintegrating Tablets110
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

96 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qilu Pharmaceutical Co., Ltd.531
2Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized515
3CSPC OUYI PHARMACEUTICAL CO., LTD.442
4Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized424
5Idience Co. Ltd.410
6Xian Tang Chen Pharmaceutical Co., Ltd. romanized330
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

48 this week

AcceptedDrugApplicants
2022/12/28Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2200353 ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited
2022/12/28Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2200352 ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited
2022/12/28Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2202118 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/28Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2202117 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/28Generic · Class 3 氟[18F]化钠注射液 · No verified English nameCYHS2202115 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/28Generic · Class 3 Carbocisteine Oral SolutionCYHS2202114 Beijing Kang Cheng Bai Chun Bio Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized
2022/12/28Generic · Class 3 Carbocisteine Oral SolutionCYHS2202113 Beijing Kang Cheng Bai Chun Bio Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized
2022/12/28Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2202112 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2022/12/28Generic · Class 3 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2202106 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/12/28New drug · Class 1 LP002注射液 · No verified English nameCXSL2200620 Tai Zhou Hou De Ao Ke Technology Co., Ltd. romanized
2022/12/28New drug · Class 1 迪诺仑赛注射液 · No verified English nameCXSL2200619 Beijing Yong Tai Rui Ke Bio Technology Co., Ltd. romanized
2022/12/28New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200955 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2022/12/28New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200954 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
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

18 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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