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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 25 April 2025 and 1 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 76 drug names.

2025/04/25 – 2025/05/01

Period
2025/04/25 to 2025/05/01, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
40

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

392filings, 88 of them generic

By application type

Application typeFilings
Supplement210
Generic88
New drug60
Import17
Unspecified10
Import re-registration6
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug265
TCM84
Therapeutic biologic35
Biologic5
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pemafibrate Tablets4423
2二甲双胍恩格列净片(Ⅰ) · No verified English name227
3Ferrous Succinate Tablets2220
4盐酸米诺环素泡沫剂 · No verified English name220
5Adapalene Gel2230
6Dimethyl Fumarate Delayed-release Capsules210
7Tandospirone Citrate Tablets212
8注射用头孢唑肟钠 · No verified English name214
9Fudosteine oral solution217
10Finerenone Tablets2169

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized41340
2Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized880
3Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized840
4Janssen-Cilag International NV830
5Guangdong Dong Yang Guang Pharma Co., Ltd. romanized630
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized550
8Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized550
9Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized544
10Guangdong Sunho Pharmaceutical Co., Ltd.510

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

101 this week

AcceptedDrugApplicants
2025/05/01Import · Class 1 177Lu-HuJ591单抗注射液 · No verified English nameJXSL2500069 Telix Pharmaceuticals (Innovations) Pty Ltd; GrandPharma (China) Co. Ltd.
2025/05/01Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2501638 Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2025/05/01Generic · Class 3 Meloxicam injectionCYHS2501635 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2025/05/01Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501634 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2025/05/01New drug · Class 1 FL115注射液 · No verified English nameCXSL2500350 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 1 BAT4406F注射液 · No verified English nameCXSL2500349 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/05/01New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500348 Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用BGB-B3227 · No verified English nameCXSL2500347 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2500346 Guangzhou Hong Run Bio Technology Co., Ltd. romanized
2025/05/01New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2500345 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2025/05/01New drug · Class 1 注射用HRS8179 · No verified English nameCXHL2500436 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500435 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500434 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500433 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500432 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/05/01New drug · Class 1 HRS-1893片 · No verified English nameCXHL2500431 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/05/01New drug · Class 1 SYN608片 · No verified English nameCXHL2500430 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/01New drug · Class 1 SYN608片 · No verified English nameCXHL2500429 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/30Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2501623 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/04/30Generic · Class 3 Famotidine InjectionCYHS2501619 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/04/30Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501617 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2025/04/30New drug · Class 1 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2500344 Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 注射用YL242 · No verified English nameCXSL2500343 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500428 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500427 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500426 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2500425 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/04/30New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2500424 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/04/29Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2500067 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2025/04/29Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2500066 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited

71 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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