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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 205 drug applications between 23 December 2022 and 29 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 32 drug names.

2022/12/23 – 2022/12/29

Period
2022/12/23 to 2022/12/29, 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
205
Drugs with new generic filings (by drug name, de-duplicated)
32
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

205filings, 46 of them generic

By application type

Application typeFilings
Supplement92
Generic46
New drug36
Import21
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug149
Therapeutic biologic28
TCM22
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

32 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
3Esmolol Hydrochloride Injection223
4Voriconazole Tablets211
5Topiramate Extended-release Capsules210
6水合氯醛灌肠剂 · No verified English name211
7Nalbuphine Hydrochloride Injection2111
8Sucralfate Oral Suspension214
9Carbocisteine Oral Solution216
10Sugammadex Sodium Injection216

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Tang Chen Pharmaceutical Co., Ltd. romanized540
2Qilu Pharmaceutical Co., Ltd.531
3Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized515
4CSPC OUYI PHARMACEUTICAL CO., LTD.442
5Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized440
6Yi Chang Ren Fu Pharma Co., Ltd. romanized423
7Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized424
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
9Idience Co. Ltd.410
10Yuan Zi Gao Ke Co., Ltd. romanized331

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

74 this week

AcceptedDrugApplicants
2022/12/29Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2202136 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/12/29Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2202135 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/12/29Generic · Class 3 Sucralfate Oral SuspensionCYHS2202134 Guangdong Zhong Sheng Pharma Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2022/12/29Generic · Class 3 Sucralfate Oral SuspensionCYHS2202133 Guangdong Zhong Sheng Pharma Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized
2022/12/29Generic · Class 3 Nicorandil for InjectionCYHS2202132 Tian Da Pharma (Yunnan) Co., Ltd. romanized
2022/12/29Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2202127 Hefei En Rui Te Pharma Co., Ltd. romanized
2022/12/29Generic · Class 3 Metaraminol Tartrate InjectionCYHS2202126 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2022/12/29Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2202125 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/29Generic · Class 3 Topiramate Extended-release CapsulesCYHS2202124 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2022/12/29Generic · Class 3 Topiramate Extended-release CapsulesCYHS2202123 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2022/12/29Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2202122 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2022/12/29Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2202121 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2022/12/29New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200624 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 注射用ATG-022 ADC · No verified English nameCXSL2200623 De Qi (Hangzhou) Bio Co., Ltd. romanized
2022/12/29New drug · Class 1 BPB-101双抗注射液 · No verified English nameCXSL2200622 Bei Da Pharma Co., Ltd. romanized
2022/12/29New drug · Class 1 CC312冻干粉针剂 · No verified English nameCXSL2200621 Hui He Bio Technology (Shanghai) Co., Ltd. romanized
2022/12/29New drug · Class 1 AZD4547片 · No verified English nameCXHL2200968 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 AZD4547片 · No verified English nameCXHL2200967 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 氟[18F]贝他嗪注射液 · No verified English nameCXHL2200966 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/29New drug · Class 1 氟[18F]司他明注射液 · No verified English nameCXHL2200965 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/29New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHL2200964 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/12/29New drug · Class 1 BPI-472372片 · No verified English nameCXHL2200963 Bei Da Pharma Co., Ltd. romanized
2022/12/29New drug · Class 1 BPI-472372片 · No verified English nameCXHL2200962 Bei Da Pharma Co., Ltd. romanized
2022/12/29New drug · Class 1 TQ05105片 · No verified English nameCXHL2200961 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/12/29New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2200960 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2200959 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 BGB-21447片 · No verified English nameCXHL2200958 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 BGB-21447片 · No verified English nameCXHL2200957 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/12/29New drug · Class 1 伊匹乌肽滴眼液 · No verified English nameCXHL2200956 Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized
2022/12/28Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2200353 ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited

44 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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