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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 22 May 2025 and 28 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 53 drug names.

2025/05/22 – 2025/05/28

Period
2025/05/22 to 2025/05/28, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
43

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

289filings, 74 of them generic

By application type

Application typeFilings
Supplement144
Generic74
New drug48
Import11
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug188
TCM46
Therapeutic biologic45
Prophylactic biologic7
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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel6330
2Dapagliflozin Tablets4284
3Brexpiprazole Orally Disintegrating Tablets3110
4Potassium Chloride Oral Solution3111
5Glucosamine Sulfate Capsules2251
6Iguratimod Tablets2223
7Aspirin Enteric-coated Tablets2210
8利伐沙班口崩片 · No verified English name214
9地氯雷他定口服溶液 · No verified English name2126
10Levothyroxine Sodium Tablets2112

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

179 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized990
2Guangdong Sunho Pharmaceutical Co., Ltd.630
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
5Jilin Sheng Qi Ke Pharma Co., Ltd. romanized440
6Haerbin Tong Yi Tang Pharma Co., Ltd. romanized440
7Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized440
8AstraZeneca AB420
9Jiangsu Deyuan Pharmaceutical Co.,Ltd.422
10CSPC OUYI PHARMACEUTICAL CO., LTD.420

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

81 this week

AcceptedDrugApplicants
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
2025/05/28Generic · Class 3 Cabergoline TabletsCYHL2500098 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/05/28New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2500428 Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized
2025/05/28New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500427 Le Pu Jian Tang Pharma (Chongqing) Co., Ltd. romanized
2025/05/28New drug · Class 1 HEC-301注射液 · No verified English nameCXSL2500426 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Shenzhen Shi Ge Bi Jia Fen Zi Drug Innovation Center Co., Ltd. romanized
2025/05/28New drug · Class 1 洛布替尼片 · No verified English nameCXHS2500057 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/05/28New drug · Class 1 洛布替尼片 · No verified English nameCXHS2500056 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/05/28New drug · Class 2.2; 2.4 MZ-01吸入溶液 · No verified English nameCXHL2500513 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/28New drug · Class 1 富马酸奥比特嗪肠溶微丸胶囊 · No verified English nameCXHL2500512 Shenzhen Shi Zhen Xing Pharmaceuticals Technology Co., Ltd. romanized
2025/05/28New drug · Class 1 SYN818片 · No verified English nameCXHL2500511 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/28New drug · Class 1 SYN818片 · No verified English nameCXHL2500510 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/05/27Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500065 UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/27Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2500064 UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd
2025/05/27Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2501884 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2501883 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(II) · No verified English nameCYHS2501882 Yu Song Yuan Pharma Co., Ltd. romanized
2025/05/27Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2501876 Hunan Run Xing Pharma Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2025/05/27Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2501874 Jinan Zhong Yu Run Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2025/05/27New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSS2500054 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized; Beijing Hua Fang Tian Shi Biopharmaceutical Co., Ltd. romanized
2025/05/27New drug · Class 1 重组人PD-L1/CD3 双抗溶瘤II型单纯疱疹病毒注射液(Vero细胞) · No verified English nameCXSL2500425 Wuhan Bin Hui Bio Technology Co., Ltd. romanized
2025/05/27New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500424 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2025/05/27New drug · Class 1 注射用RMMV疫苗 · No verified English nameCXSL2500423 Changchun Kang Yue Bio Technology Co., Ltd. romanized

51 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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