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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 27 November 2023 and 3 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 56 drug names.

2023/11/27 – 2023/12/03

Period
2023/11/27 to 2023/12/03, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
56
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

308filings, 68 of them generic

By application type

Application typeFilings
Supplement161
Generic68
New drug53
Import21
Import re-registration3
Unspecified2

By drug type

Drug typeFilings
Chemical drug199
Therapeutic biologic57
TCM45
Prophylactic biologic5
Biologic2

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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2地氯雷他定口服溶液 · No verified English name3126
3Acetylcysteine Injection2253
4Moxifloxacin Hydrochloride Eye Drops224
5Risperidone Tablets210
6布洛芬混悬滴剂 · No verified English name210
7Sildenafil Citrate Tablets2112
8Amisulpride Injection211
9Thioctic Acid Tablets214
10Roxadustat Capsules2117

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

191 companies with new acceptances; top 10 listed

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

103 this week

AcceptedDrugApplicants
2023/12/02Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2300085 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/12/02Import · Class 1 AZD5305 · No verified English nameJXHL2300300 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/02Import · Class 1 AZD5305 · No verified English nameJXHL2300299 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/02Import · Class 1 AZD5305 · No verified English nameJXHL2300298 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/02Import · Class 1 AZD5305 · No verified English nameJXHL2300297 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/12/02Generic · Class 3 富马酸酮替芬滴眼液 · No verified English nameCYHS2303334 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/12/02Generic · Class 3 Indocyaninegreen for InjectionCYHS2303332 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2023/12/02New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSS2300089 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/12/02New drug · Class 2.2 葡萄糖口服溶液 · No verified English nameCXHS2300109 Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized
2023/12/02New drug · Class 2.2 SXF-103口溶膜 · No verified English nameCXHL2301331 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2023/12/01Import · Class 1 注射用Zetomipzomib · No verified English nameJXHL2300296 Kezar Life Sciences Inc.; Everest Medicines (China) Co. Ltd.
2023/12/01Generic · Class 3 Ozagrel Sodium InjectionCYHS2303328 Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/12/01Generic · Class 3 Indobufen TabletsCYHS2303321 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2023/12/01New drug · Class 1 LAE102注射液 · No verified English nameCXSL2300836 Lai Kai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/01New drug · Class 1 注射用DB-1303 · No verified English nameCXSL2300835 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/12/01New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300834 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2300833 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/12/01New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2300832 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2023/12/01New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2300831 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 注射用菲泽妥单抗 · No verified English nameCXSL2300830 Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized
2023/12/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300829 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2023/12/01New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300828 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2023/12/01New drug · Class 2.2 KEM2105缓释片 · No verified English nameCXHL2301330 Changsha Jing Yi Pharmaceuticals Technology Co., Ltd. romanized
2023/12/01New drug · Class 1 HRS2398片 · No verified English nameCXHL2301329 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 HRS2398片 · No verified English nameCXHL2301328 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 CPU-216片 · No verified English nameCXHL2301327 Zhongguo Yao Ke University romanized; Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized
2023/12/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301326 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301325 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/12/01New drug · Class 1 HRS-1167片 · No verified English nameCXHL2301324 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/30Import · Class 1 ALXN1850注射液 · No verified English nameJXSL2300215 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.

73 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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