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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 403 drug applications between 12 March 2025 and 18 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 66 drug names.

2025/03/12 – 2025/03/18

Period
2025/03/12 to 2025/03/18, 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
403
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
25

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

403filings, 95 of them generic

By application type

Application typeFilings
Supplement193
Generic95
New drug53
Import22
Import re-registration22
Unspecified18

By drug type

Drug typeFilings
Chemical drug300
TCM52
Therapeutic biologic44
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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name4226
2Sacubitril Valsartan Sodium Tablets4270
3Lactulose Oral Solution3234
4Riociguat Tablets314
5Levofloxacin and Sodium Chloride Injection3114
6腺苷钴胺胶囊 · No verified English name228
7Famotidine Injection218
8Hydrocortisone Sodium Succinate for Injection2116
9Ciclosporin Soft Capsules212
10Edoxaban Tosilate Tablets219

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized17160
2Bracco Imaging S.P.A.1310
3Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized880
4Hunan Jiudian Pharmaceutical Co., Ltd650
5Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized630
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
7AstraZeneca AB530
8Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized440
9Zhongguo Ke College Shanghai Drug Research Institute romanized430
10Sanofi Winthrop Industrie420

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

110 this week

AcceptedDrugApplicants
2025/03/18Import · Class 2.4 地非法林注射液 · No verified English nameJXHL2500049 Vifor Fresenius Medical Care Renal Pharma Ltd.; Zhejiang Medical Technology Development Co. LTD.
2025/03/18Import · Class 1 VSA001注射液 · No verified English nameJXHL2500048 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2025/03/18Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501100 Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/18Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501099 Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/18Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2501097 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501096 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501095 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2501092 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501090 Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501089 Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2501088 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2501087 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/18New drug · Class 1 IBI363 · No verified English nameCXSL2500233 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/03/18New drug · Class 1 IBI363 · No verified English nameCXSL2500232 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/03/18New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500231 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/03/18New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2500230 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/03/18New drug · Class 2.5 吸附组分无细胞百白破(减剂量)联合疫苗 · No verified English nameCXSL2500229 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2025/03/18New drug · Class 2.5 吸附组分无细胞百白破(减剂量)联合疫苗 · No verified English nameCXSL2500228 Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized
2025/03/18New drug · Class 1 TP1001 片 · No verified English nameCXHL2500300 Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/18New drug · Class 1 TP1001 片 · No verified English nameCXHL2500299 Sheng Yuan Ze Tong (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/18New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2500298 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/03/18New drug · Class 1 RFUS-949片 · No verified English nameCXHL2500297 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/03/18New drug · Class 1 RFUS-949片 · No verified English nameCXHL2500296 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/03/18New drug · Class 1 GST-HG131片 · No verified English nameCXHL2500295 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2025/03/18New drug · Class 1 GST-HG131片 · No verified English nameCXHL2500294 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2025/03/18New drug · Class 1 奈瑞可韦片 · No verified English nameCXHL2500293 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2025/03/18New drug · Class 1 奈瑞可韦片 · No verified English nameCXHL2500292 Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized
2025/03/17Import · Class 1 [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500047 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/15Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2500026 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/03/15Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSS2500025 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.

80 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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