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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 23 August 2025 and 29 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 71 drug names.

2025/08/23 – 2025/08/29

Period
2025/08/23 to 2025/08/29, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
88

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

404filings, 102 of them generic

By application type

Application typeFilings
Supplement187
Generic102
New drug73
Import32
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug286
TCM63
Therapeutic biologic49
Biologic3
Prophylactic biologic2
Unspecified1

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

71 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection410
2瑞维那新吸入溶液 · No verified English name3353
3Apalutamide Tablets3318
4Ambroxol Hydrochloride Injection319
5Memantine Hydrochloride OD Tablets312
6Polidocanol Injection3123
7Isavuconazonium Sulfate for Injection2215
8甘油磷酸钠注射液 · No verified English name227
9Iguratimod Tablets2223
10利伐沙班口崩片 · No verified English name214

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

225 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1720
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1290
3NAPP PHARMACEUTICALS LIMITED910
4CSPC OUYI PHARMACEUTICAL CO., LTD.755
5Janssen-Cilag International NV730
6Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized660
7AstraZeneca AB520
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
9Qilu Pharmaceutical Co., Ltd.510
10Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized440

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

137 this week

AcceptedDrugApplicants
2025/08/29Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503175 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2025/08/29Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2503173 Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized
2025/08/29Generic · Class 3 盐酸地尔硫?控释胶囊 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2503164 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/08/29Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2503163 Qian Hai Shi De Tang (He Bi) Pharmaceutical Co., Ltd. romanized
2025/08/29Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2503162 Qian Hai Shi De Tang (He Bi) Pharmaceutical Co., Ltd. romanized
2025/08/29Generic · Class 3 Leuprorelin Acetate Microspheres for InjectionCYHL2500159 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/29Generic · Class 3 Ketoprofen PatchesCYHL2500157 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2025/08/29New drug · Class 1.1 保精片 · No verified English nameCXZL2500069 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2025/08/29New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500749 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 ARC001滴鼻液 · No verified English nameCXSL2500748 Name not romanized
2025/08/29New drug · Class 1 ARC001注射液 · No verified English nameCXSL2500747 Name not romanized
2025/08/29New drug · Class 1 AK152注射液 · No verified English nameCXSL2500746 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2500927 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2025/08/29New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2500926 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2025/08/29New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2500925 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2025/08/29New drug · Class 1 JMKX000189片 · No verified English nameCXHL2500924 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 JMKX000189片 · No verified English nameCXHL2500923 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 JMKX000189片 · No verified English nameCXHL2500922 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 XNW34017片 · No verified English nameCXHL2500921 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 ANS014004片 · No verified English nameCXHL2500920 Beijing An Shi Bio Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 XNW34017片 · No verified English nameCXHL2500919 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 ANS014004片 · No verified English nameCXHL2500918 Beijing An Shi Bio Technology Co., Ltd. romanized
2025/08/29New drug · Class 1 ST-01156胶囊 · No verified English nameCXHL2500917 Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 1 ST-01156胶囊 · No verified English nameCXHL2500916 Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 1 ST-01156胶囊 · No verified English nameCXHL2500915 Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 1 ST-01156胶囊 · No verified English nameCXHL2500914 Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 2.4 富马酸泰吉利定注射液 · No verified English nameCXHL2500913 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 2.4 富马酸泰吉利定注射液 · No verified English nameCXHL2500912 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/29New drug · Class 2.2 JL4083吸入溶液 · No verified English nameCXHL2500911 Sichuan Jian Lin Pharma Co., Ltd. romanized
2025/08/29New drug · Class 2.2 JL4083吸入溶液 · No verified English nameCXHL2500910 Sichuan Jian Lin Pharma Co., Ltd. romanized

107 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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