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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 324 drug applications between 15 March 2025 and 21 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 59 drug names.

2025/03/15 – 2025/03/21

Period
2025/03/15 to 2025/03/21, 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
324
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
21

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

324filings, 77 of them generic

By application type

Application typeFilings
Supplement173
Generic77
New drug53
Unspecified11
Import8
Import re-registration2

By drug type

Drug typeFilings
Chemical drug229
TCM48
Therapeutic biologic41
Prophylactic biologic6

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mupirocin Ointment3130
2氧(气态) · No verified English name221
3Sodium Iodide[131I] Oral Solution222
4Canagliflozin Tablets218
5Vonoprazan Fumarate Tablets2160
6Hydrocortisone Sodium Succinate for Injection2116
7Loxoprofen Sodium Patches2130
8Edoxaban Tosilate Tablets219
9Lidocaine Hydrochloride Injection216
10Bupivacaine Hydrochloride Injection214

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized880
2Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized880
3Roche Pharma (Schweiz) AG810
4Hunan Jiudian Pharmaceutical Co., Ltd650
5Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized630
6Yi Chang Ren Fu Pharma Co., Ltd. romanized530
7Henan Pu Rui Pharma Co., Ltd. romanized535
8Sichuan Kelun Pharmaceutical Co., Ltd.510
9Li Bang Pharma (Shanghai) Co., Ltd. romanized510
10Zhongguo Ke College Shanghai Drug Research Institute romanized430

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

94 this week

AcceptedDrugApplicants
2025/03/21Generic · Class 3 Sodium Iodide[131I] Oral SolutionCYHS2501145 Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized
2025/03/21Generic · Class 3 Acetazolamide TabletsCYHS2501142 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2025/03/21New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2500037 Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2025/03/21New drug · Class 1 BT02单克隆抗体注射液 · No verified English nameCXSL2500236 Shanghai Bai Quan Bio Technology Co., Ltd. romanized
2025/03/21New drug · Class 2.4 ZHCX002 · No verified English nameCXHL2500313 Jiu Hua Hua Yuan Pharma Co., Ltd. romanized
2025/03/21New drug · Class 1 NH104片 · No verified English nameCXHL2500312 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/03/21New drug · Class 1 NH104片 · No verified English nameCXHL2500311 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/03/21New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2500310 Shanghai Shyndec Pharmaceutical Co., Ltd.
2025/03/21New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2500309 Shanghai Shyndec Pharmaceutical Co., Ltd.
2025/03/21New drug · Class 1 ICP-248片 · No verified English nameCXHL2500308 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/03/21New drug · Class 1 ICP-248片 · No verified English nameCXHL2500307 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/03/20Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2501128 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501127 Hubei Tian Sheng Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Sodium Iodide[131I] Oral SolutionCYHS2501125 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2025/03/20Generic · Class 3 Furosemide InjectionCYHS2501124 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/20Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2501120 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 福多司坦片 · No verified English nameCYHS2501117 Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2501116 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2501115 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2501114 Duo Duo Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Elagolix Sodium TabletsCYHL2500063 Dong Guan Song Shan Hu Mei Jian Bio Technology Co., Ltd. romanized
2025/03/20Generic · Class 3 Elagolix Sodium TabletsCYHL2500062 Dong Guan Song Shan Hu Mei Jian Bio Technology Co., Ltd. romanized
2025/03/20New drug · Class 1.1 天苓止眩片 · No verified English nameCXZL2500019 Hunan Zhong Pharmaceuticals University romanized
2025/03/19Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501112 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 酒石酸阿福特罗吸入溶液 · No verified English nameCYHS2501111 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/03/19Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2501110 Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2501105 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2025/03/19Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2501104 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 Gatifloxacin Eye DropsCYHS2501102 Hefei Nuo Rui Te Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized
2025/03/19New drug · Class 2.3 松龄血脉康胶囊 · No verified English nameCXZL2500018 Chengdu Kang Hong Pharmaceutical Co., Ltd. romanized

64 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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