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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 282 drug applications between 4 May 2024 and 10 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 64 drug names.

2024/05/04 – 2024/05/10

Period
2024/05/04 to 2024/05/10, 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
282
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
0

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

282filings, 84 of them generic

By application type

Application typeFilings
Supplement113
Generic84
New drug55
Import16
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug189
Therapeutic biologic49
TCM42
Prophylactic biologic2

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Fluvoxamine Maleate Tablets320
3Telmisartan Tablets314
4Deutetrabenazine Tablets310
5聚乙二醇钠钾散 · No verified English name223
6Lactulose Oral Solution2134
7二甲硅油乳剂 · No verified English name2114
8Perampanel Tablets212
9Procaterol Hydrochloride Solution for Inhalation212
10头孢地尼干混悬剂 · No verified English name212

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Di Liu Pharmaceutical Co., Ltd. romanized750
2Chongqing Sai Wei Pharma Co., Ltd. romanized722
3Bai Ao Tai Biopharmaceutical Co., Ltd. romanized630
4Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.623
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
6Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized550
7AstraZeneca AB430
8Takeda Pharmaceuticals International AG Ireland Branch420
9Topfond Pharmaceutical Co., Ltd.424
10Shandong Lv Ye Pharmaceutical Co., Ltd. romanized410

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

102 this week

AcceptedDrugApplicants
2024/05/10Import · Class 1 BAY 3375968 · No verified English nameJXSL2400088 Bayer AG; Bayer Healthcare Company Ltd.
2024/05/10Import · Class 1 BI 690517片 · No verified English nameJXHL2400105 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/05/10Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2401400 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/05/10Generic · Class 3 Indobufen TabletsCYHS2401392 Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized
2024/05/10Generic · Class 3 Doxylamine Succinate TabletsCYHL2400088 Jiangxi Xin Gan Jiang Pharma Co., Ltd. romanized
2024/05/10Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400087 Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2024/05/10Generic · Class 3 Doxepin Hydrochloride TabletsCYHL2400086 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/05/10Generic · Class 3 Doxepin Hydrochloride TabletsCYHL2400085 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/05/10Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400084 Beijing Han Mei Medicines Co., Ltd. romanized
2024/05/10New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2400304 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/05/10New drug · Class 1 KAL-003 · No verified English nameCXSL2400303 Chengdu Yan Yang Jun Bio Technology Co., Ltd. romanized; Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/05/10New drug · Class 1 KAL-003 · No verified English nameCXSL2400302 Chengdu Yan Yang Jun Bio Technology Co., Ltd. romanized; Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/05/10New drug · Class 1 注射用BG-C9074 · No verified English nameCXSL2400301 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/05/10New drug · Class 1 RC1416注射液 · No verified English nameCXSL2400300 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2024/05/10New drug · Class 1 RC1416注射液 · No verified English nameCXSL2400299 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2024/05/10New drug · Class 1 IBI354 · No verified English nameCXSL2400298 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/10New drug · Class 1 LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400456 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/05/10New drug · Class 1 LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400455 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/05/10New drug · Class 1 LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400454 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/05/10New drug · Class 1 LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400453 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-1358片 · No verified English nameCXHL2400452 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-1358片 · No verified English nameCXHL2400451 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400450 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400449 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400448 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400447 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400446 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400445 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400444 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/10New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400443 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

72 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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