YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 19 May 2025 and 25 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 50 drug names.

2025/05/19 – 2025/05/25

Period
2025/05/19 to 2025/05/25, 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
317
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
46

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

317filings, 69 of them generic

By application type

Application typeFilings
Supplement157
Generic69
New drug64
Import15
Unspecified10
Import re-registration2

By drug type

Drug typeFilings
Chemical drug194
TCM59
Therapeutic biologic58
Prophylactic biologic5
Biologic1

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel4230
2Brexpiprazole Orally Disintegrating Tablets3110
3Potassium Chloride Oral Solution3111
4维立西呱片 · No verified English name318
5Glucosamine Sulfate Capsules2251
6Iguratimod Tablets2223
7丙戊酸钠缓释微片 · No verified English name210
8地氯雷他定口服溶液 · No verified English name2126
9Vonoprazan Fumarate Tablets2160
10Methylprednisolone Sodium Succinate for injection2112

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

195 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized20190
2AstraZeneca AB940
3Guangdong Sunho Pharmaceutical Co., Ltd.630
4Changzhou Pharmaceutical Factory Co., Ltd. romanized525
5Zhong Mei Shanghai Shi Gui Bao Pharmaceutical Co., Ltd. romanized440
6Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized440
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
8Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized420
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420
10Lilly del Caribe Inc.410

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
2025/05/24Import · Class 1 注射用Felzartamab · No verified English nameJXSL2500082 Biogen Idec Research Limited
2025/05/24New drug · Class 2.2 瑞基奥仑赛注射液 · No verified English nameCXSS2500053 Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized; Suzhou Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 IBI363 · No verified English nameCXSL2500421 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/24New drug · Class 1 IBI363 · No verified English nameCXSL2500420 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/24New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2500419 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/05/24New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2500418 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500509 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500508 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500507 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 1 VB19055片 · No verified English nameCXHL2500506 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/05/24New drug · Class 2.2 HKG-456 · No verified English nameCXHL2500505 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized
2025/05/23Import · Class 1 GHZ339注射液 · No verified English nameJXSL2500081 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501864 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501863 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2501862 Hangzhou He Kang Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Hydrotalcite SuspensionCYHS2501860 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/23Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2501853 Hubei Tian Sheng Pharma Co., Ltd. romanized
2025/05/23Generic · Class 3 Potassium Phosphates InjectionCYHS2501851 Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized
2025/05/23New drug · Class 1.1 通利肠溶胶囊 · No verified English nameCXZS2500022 Rong Chang Pharmaceutical (Zi Bo) Co., Ltd. romanized
2025/05/23New drug · Class 3.1 完带颗粒 · No verified English nameCXZS2500021 Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2025/05/23New drug · Class 1.1 固本清肺颗粒 · No verified English nameCXZL2500031 Shenzhen Shi Zhong Hospital romanized
2025/05/23New drug · Class 1.1 紫英颗粒 · No verified English nameCXZL2500030 Guangdong Fang Sheng Rong Ke Pharma Co., Ltd. romanized
2025/05/23New drug · Class 3.3 注射用SIM0692 · No verified English nameCXSL2500417 Shandong Xian Sheng Biopharmaceutical Co., Ltd. romanized
2025/05/23New drug · Class 1 SHR-7782注射液 · No verified English nameCXSL2500416 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/05/23New drug · Class 1 SNUG01 · No verified English nameCXSL2500415 Shen Ji Chang Hua (Beijing) Bio Technology Co., Ltd. romanized
2025/05/23New drug · Class 1 斯乐韦米单抗注射液 · No verified English nameCXSL2500414 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/05/23New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHL2500504 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2025/05/23New drug · Class 1 BGB-45035片 · No verified English nameCXHL2500503 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/05/22Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2500080 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2025/05/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2501850 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized

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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