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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 21 September 2026 and 27 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 48 drug names.

2026/09/21 – 2026/09/27

Period
2026/09/21 to 2026/09/27, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
313

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

390filings, 60 of them generic

By application type

Application typeFilings
Supplement224
Generic60
New drug54
Import23
Import re-registration15
Unspecified14

By drug type

Drug typeFilings
Chemical drug209
TCM103
Therapeutic biologic69
Biologic7
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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1盐酸西替利嗪滴眼液 · No verified English name333
2Baricitinib Tablets3232
3Ertugliflozin Tablets2213
4Brimonidine Tartrate Eye Drops224
5Sildenafil Citrate Tablets2112
6Tranexamic Acid Tablets219
7Nafamostat Mesilate for Injection2138
8Repaglinide Tablets216
9Dapagliflozin Tablets2184
10Axitinib Tablets215

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

249 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized920
2Bayer Vital GmbH910
3Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized610
5Xian Wan Long Pharmaceutical Co., Ltd. romanized550
6Jiangxi Pin Xin Pharma Co., Ltd. romanized520
7Boehringer Ingelheim International GmbH510
8Yuan Da Bei Lin (Xian) Pharma Co., Ltd. romanized440
9Te Yi Pharma Group Co., Ltd. romanized422
10Eli Lilly Nederland B.V.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

93 this week

AcceptedDrugApplicants
2026/09/24Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2600260 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/09/24Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2600123 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2600122 Eisai Europe Limited; Eisai Co. Ltd.
2026/09/24Import · Class 2.4 赛沃替尼片 · No verified English nameJXHL2600417 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/09/24Generic · Class 3 Bilastine Oral SolutionCYHS2602414 Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/09/24Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2602413 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2026/09/24Generic · Class 3 Ciclosporin Eye Drops(Ⅱ)CYHS2602410 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2026/09/24Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2602409 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2026/09/24Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2602407 Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2026/09/24Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2602406 Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2026/09/24Generic · Class 3 辅酶Q??片 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2602404 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/09/24Generic · Class 3 Peramivir InjectionCYHS2602403 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2026/09/24Generic · Class 3 罂粟乙碘油注射液 · No verified English nameCYHL2600103 Hainan Brilliant Pharmaceutical Co., Ltd.
2026/09/24New drug · Class 1 注射用HS-20093 · No verified English nameCXSS2600155 Changzhou Heng Bang Pharma Co., Ltd. romanized; Name not romanized
2026/09/24New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSS2600154 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2026/09/24New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2601064 Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized; Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized
2026/09/24New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2601063 Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized; Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized
2026/09/24New drug · Class 2.2 伏欣奇拜单抗注射液 · No verified English nameCXSL2601062 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/09/24New drug · Class 2.2 伏欣奇拜单抗注射液 · No verified English nameCXSL2601061 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/09/24New drug · Class 1 C2403细胞注射液 · No verified English nameCXSL2601060 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2026/09/24New drug · Class 1 LVRNA018 · No verified English nameCXSL2601059 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized
2026/09/24New drug · Class 1 LK101注射液 · No verified English nameCXSL2601058 Beijing Li Kang Sheng Ming Technology Co., Ltd. romanized
2026/09/24New drug · Class 1 QM101细胞注射液(异体) · No verified English nameCXSL2601057 Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized
2026/09/24New drug · Class 1 VV312片 · No verified English nameCXHL2601204 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2026/09/24New drug · Class 1 VV312片 · No verified English nameCXHL2601203 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2026/09/24New drug · Class 1 VV312片 · No verified English nameCXHL2601202 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2026/09/24New drug · Class 1 氟[18F]思睿肽注射液 · No verified English nameCXHL2601201 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2026/09/24New drug · Class 1 LT-002-158片 · No verified English nameCXHL2601200 Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized
2026/09/23Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2600259 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/09/23Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600258 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd

63 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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