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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 622 drug applications between 10 October 2025 and 16 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 94 drug names.

2025/10/10 – 2025/10/16

Period
2025/10/10 to 2025/10/16, 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
622
Drugs with new generic filings (by drug name, de-duplicated)
94
Accepted this week, now under review
145

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

622filings, 121 of them generic

By application type

Application typeFilings
Supplement308
New drug125
Generic121
Import34
Unspecified26
Import re-registration8

By drug type

Drug typeFilings
Chemical drug373
TCM133
Therapeutic biologic86
Biologic19
Prophylactic biologic7
Unspecified3
In vitro diagnostic reagent1

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

94 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Ambroxol Hydrochloride Oral Solution3246
3甘油灌肠剂 · No verified English name312
4甲苯磺酸卢美哌隆胶囊 · No verified English name312
5LevomilnacipranHydrochloride Extended-release Capsules316
6达普司他片 · No verified English name310
7Pemafibrate Tablets2223
8Vortioxetine Hydrobromide Tablets2210
9Glucosamine Sulfate Capsules2251
10磷酸奥司他韦颗粒 · No verified English name2212

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

328 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized45300
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1020
3Qilu Pharmaceutical Co., Ltd.953
4AstraZeneca AB940
5Bristol-Myers Squibb Company820
6Actelion Pharmaceuticals Ltd810
7Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized770
8Zhongshan Wanhan Pharmaceuticals Co., Ltd.732
9Wyeth Pharmaceutical Division of Wyeth Holdings LLC660
10Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized660

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

202 this week

AcceptedDrugApplicants
2025/10/16Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2500133 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/16Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2500132 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/16Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSL2500201 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500320 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500319 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500318 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500317 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500316 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/10/16Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2503712 Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2025/10/16Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503708 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/10/16Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503707 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/10/16Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2503706 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/10/16Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2503697 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/10/16Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503692 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2025/10/16Generic · Class 3 盐酸伊伐布雷定口服溶液 · No verified English nameCYHS2503690 Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2025/10/16Generic · Class 3 Tretinoin CreamCYHL2500188 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/10/16New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2500115 Zhejiang Hua Hai Bio Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 注射用SIM0610 · No verified English nameCXSL2500892 Shanghai Xian Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/10/16New drug · Class 2.2 基因减毒组分百白破联合疫苗 · No verified English nameCXSL2500891 Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2500890 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 富马酸奥比特嗪肠溶微丸胶囊 · No verified English nameCXHL2501133 Shenzhen Shi Zhen Xing Pharmaceuticals Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 注射用美罗培南普莱巴坦 · No verified English nameCXHL2501132 Qilu Pharmaceutical Co., Ltd.
2025/10/16New drug · Class 1 ABSK141片 · No verified English nameCXHL2501131 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 注射用美罗培南普莱巴坦 · No verified English nameCXHL2501130 Qilu Pharmaceutical Co., Ltd.
2025/10/16New drug · Class 1 ABSK141片 · No verified English nameCXHL2501129 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/16New drug · Class 1 HRS-5041片 · No verified English nameCXHL2501128 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/16New drug · Class 1 HRS-5041片 · No verified English nameCXHL2501127 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/16New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2501126 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/10/16New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2501125 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/10/16New drug · Class 1 SYH2069注射液 · No verified English nameCXHL2501124 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.

172 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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