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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 268 drug applications between 27 December 2023 and 2 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 61 drug names.

2023/12/27 – 2024/01/02

Period
2023/12/27 to 2024/01/02, 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
268
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
1

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

268filings, 76 of them generic

By application type

Application typeFilings
Supplement110
Generic76
New drug63
Import re-registration10
Import7
Unspecified2

By drug type

Drug typeFilings
Chemical drug204
TCM31
Therapeutic biologic28
Prophylactic biologic5

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection412
2Lidocaine and Prilocaine Cream2224
3氧 · No verified English name2215
4Nicorandil for Injection221
5Calcipotriol and Betamethasone Ointment211
6Levofloxacin and Sodium Chloride Injection2114
7左羟丙哌嗪口服溶液 · No verified English name218
8注射用头孢唑肟钠 · No verified English name214
9Dopamine Hydrochloride Injection213
10Azilsartan Medoxomil Potassium Tablets2135

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

165 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized766
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
3Boehringer Ingelheim International GmbH510
4Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized510
5Jilin San Jiu Jin Fu Kang Pharma Co., Ltd. romanized440
6Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized440
7Guo Yao Group Tong Ji Tang (Guizhou) Pharmaceutical Co., Ltd. romanized420
8Shandong Luo Xin Pharma Group Co., Ltd. romanized420
9Bayer AG410
10Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized410

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

109 this week

AcceptedDrugApplicants
2023/12/30Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2300095 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2023/12/30Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2300094 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2023/12/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2303686 Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303684 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303683 Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2023/12/30Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2303682 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2303681 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2023/12/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2300101 Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2300909 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 3HP-2827片 · No verified English nameCXHL2301485 Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 3HP-2827片 · No verified English nameCXHL2301484 Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized
2023/12/30New drug · Class 1 INV-1120胶囊 · No verified English nameCXHL2301483 Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 INV-1120胶囊 · No verified English nameCXHL2301482 Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 KPG-818胶囊 · No verified English nameCXHL2301481 Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized
2023/12/30New drug · Class 1 KPG-818胶囊 · No verified English nameCXHL2301480 Kang Pu Biopharmaceuticals Technology (Hefei) Co., Ltd. romanized
2023/12/30New drug · Class 1 GT919胶囊 · No verified English nameCXHL2301479 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/30New drug · Class 1 GT919胶囊 · No verified English nameCXHL2301478 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/30New drug · Class 1 GT919胶囊 · No verified English nameCXHL2301477 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/30New drug · Class 1 ABP-745片 · No verified English nameCXHL2301476 Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 ABP-745片 · No verified English nameCXHL2301475 Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 ABP-745片 · No verified English nameCXHL2301474 Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 HX101胶囊 · No verified English nameCXHL2301473 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/30New drug · Class 1 CYH001肠溶胶囊 · No verified English nameCXHL2301472 Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 CYH001肠溶胶囊 · No verified English nameCXHL2301471 Beijing Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized
2023/12/30New drug · Class 1 XP-102SC胶囊 · No verified English nameCXHL2301470 Xu Nuo Pharma (Nanjing) Co., Ltd. romanized
2023/12/29Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2303677 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/12/29Generic · Class 3 Metaraminol Tartrate InjectionCYHS2303676 Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/12/29Generic · Class 3 Sodium Bicarbonate InjectionCYHS2303675 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/12/29Generic · Class 3 Nicorandil for InjectionCYHS2303672 Hebei Long Hai Pharma Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2023/12/29Generic · Class 3 Azithromycin Eye DropsCYHL2300168 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized

79 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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