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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 23 May 2025 and 29 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.

2025/05/23 – 2025/05/29

Period
2025/05/23 to 2025/05/29, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
54
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

301filings, 77 of them generic

By application type

Application typeFilings
Supplement149
Generic77
New drug51
Import10
Unspecified7
Import re-registration6
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug194
TCM50
Therapeutic biologic45
Prophylactic biologic8
Biologic4

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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel6330
2Acetylcysteine Injection4453
3Brexpiprazole Tablets4231
4Dapagliflozin Tablets4284
5Brexpiprazole Orally Disintegrating Tablets3110
6Glucosamine Sulfate Capsules2251
7Aspirin Enteric-coated Tablets2210
8利伐沙班口崩片 · No verified English name214
9Levothyroxine Sodium Tablets2112
10Levobupivacaine Hydrochloride Injection212

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized990
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
3Hangzhou He Kang Pharma Co., Ltd. romanized626
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
5Guangdong Sunho Pharmaceutical Co., Ltd.520
6Jilin Sheng Qi Ke Pharma Co., Ltd. romanized440
7Haerbin Tong Yi Tang Pharma Co., Ltd. romanized440
8Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized440
9CSPC OUYI PHARMACEUTICAL CO., LTD.420
10UCB Pharma S.A.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

80 this week

AcceptedDrugApplicants
2025/05/29Import · Class 1 Giredestrant · No verified English nameJXHL2500122 Genentech Inc.; Roche (China) Holding Ltd.
2025/05/29Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2501921 Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/05/29Generic · Class 3 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2501913 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/29Generic · Class 3 Deoxycholic Acid InjectionCYHL2500099 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/05/29New drug · Class 1.2 JMZ-2102胶囊 · No verified English nameCXZL2500034 Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1.2 JMZ-2102 · No verified English nameCXZL2500033 Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1.1 健脾疏肝固本颗粒 · No verified English nameCXZL2500032 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用YL201 · No verified English nameCXSL2500436 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/05/29New drug · Class 1 IBI363 · No verified English nameCXSL2500435 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 IBI363 · No verified English nameCXSL2500434 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用MHB088C · No verified English nameCXSL2500433 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用MHB039A · No verified English nameCXSL2500432 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/05/29New drug · Class 1 注射用HB0043 · No verified English nameCXSL2500431 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/05/29New drug · Class 1.1 鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体) · No verified English nameCXSL2500430 Guangzhou Si An Xin Bio Technology Co., Ltd. romanized
2025/05/29New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂) · No verified English nameCXSL2500429 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2025/05/29New drug · Class 1 RO7840734 · No verified English nameCXHL2500519 Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2025/05/29New drug · Class 1 RO7840734 · No verified English nameCXHL2500518 Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2025/05/29New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHL2500517 Hunan Mai Ou Medical Technology Co., Ltd. romanized
2025/05/29New drug · Class 2.2 硫酸阿托品滴眼液 · No verified English nameCXHL2500516 Hunan Mai Ou Medical Technology Co., Ltd. romanized
2025/05/29New drug · Class 2.2 KEM2417缓释干混悬剂 · No verified English nameCXHL2500515 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/05/29New drug · Class 2.2 KEM2417缓释干混悬剂 · No verified English nameCXHL2500514 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/05/28Import · Class 2.2 注射用维泊妥珠单抗 · No verified English nameJXSS2500069 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2025/05/28Import · Class 2.2 注射用维泊妥珠单抗 · No verified English nameJXSS2500068 Roche Pharma (Schweiz) AG; BSP Pharmaceuticals S.p.A.; Roche (China) Holding Ltd.
2025/05/28Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500067 UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/28Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500066 UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/28Generic · Class 3 Amisulpride Oral SolutionCYHS2501908 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2025/05/28Generic · Class 3 注射用盐酸头孢替安/氯化钠注射液 · No verified English nameCYHS2501904 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/05/28Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2501901 Nanjing Hai Jing Pharma Co., Ltd. romanized
2025/05/28Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2501900 Nanjing Hai Jing Pharma Co., Ltd. romanized
2025/05/28Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2501895 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized

50 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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