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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 159 drug applications between 3 October 2023 and 9 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 34 drug names.

2023/10/03 – 2023/10/09

Period
2023/10/03 to 2023/10/09, 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
159
Drugs with new generic filings (by drug name, de-duplicated)
34
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

159filings, 42 of them generic

By application type

Application typeFilings
Supplement61
Generic42
New drug33
Import re-registration13
Unspecified5
Import4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug108
Therapeutic biologic30
TCM20
Prophylactic biologic1

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lacosamide Tablets210
2Sacubitril Valsartan Sodium Tablets2170
3注射用头孢唑肟钠 · No verified English name214
4Sodium Hyaluronate Eye Drops2130
5Dapoxetine Hydrochloride Tablets2120
6Iopromide Injection2127
7Minoxidil Liniment2152
8Calcium Gluconate in Sodium Chloride Injection215
9Lactulose Oral Solution1134
10Ebastine Oral Solution119

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

103 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD631
2Jiangsu En Hua Pharma Co., Ltd. romanized620
3Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized535
4Eli Lilly Nederland B.V.410
5Sanofi-Aventis Deutschland GmbH410
6Name not romanized410
7Jiangxi Qing Feng Pharma Co., Ltd. romanized330
8Chongqing Xi Er An Pharma Co., Ltd. romanized330
9Jiangsu Hao Sen Pharma Group Co., Ltd. romanized320
10Chugai Pharmaceutical Co. Ltd310

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

51 this week

AcceptedDrugApplicants
2023/10/09Import · Class 1 DS-1062a · No verified English nameJXSL2300173 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/10/09Import · Class 2.4 氯马昔巴特口服溶液 · No verified English nameJXHS2300094 Mirum Pharmaceuticals Inc.; Halo Pharmaceutical Canada Inc.; CANbridge (Suzhou) Bio-pharma Co. Ltd.
2023/10/09Generic · Class 3 Ebastine Oral SolutionCYHS2302665 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302663 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2302661 Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized
2023/10/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2302660 Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized
2023/10/09Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2302659 Anhui Chang Jiang Pharma Co., Ltd. romanized
2023/10/09Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302657 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/10/09Generic · Class 3 Digoxin TabletsCYHS2302653 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2302645 Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Minoxidil LinimentCYHS2302644 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/10/09Generic · Class 3 Minoxidil LinimentCYHS2302643 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/10/09Generic · Class 3 Aceclofenac TabletsCYHS2302640 Henan Nuo Mei Pharma Co., Ltd. romanized
2023/10/09Generic · Class 3 Dapsone GelCYHL2300126 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 注射用BB-1710 · No verified English nameCXSL2300678 Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2023/10/09New drug · Class 1 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2300677 Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSL2300676 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 3.2 注射用重组人C1酯酶抑制剂 · No verified English nameCXSL2300673 Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/10/09New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300672 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/10/09New drug · Class 1 注射用AP026 · No verified English nameCXSL2300671 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/10/09New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300670 Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 注射用双利司他 · No verified English nameCXHS2300092 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/10/09New drug · Class 1 ND-003片 · No verified English nameCXHL2301059 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2023/10/09New drug · Class 1 ND-003片 · No verified English nameCXHL2301058 Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized
2023/10/09New drug · Class 1 CAN1012 注射液 · No verified English nameCXHL2301057 Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 CAN1012 注射液 · No verified English nameCXHL2301056 Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 CAN1012 注射液 · No verified English nameCXHL2301055 Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 SIR2446M片 · No verified English nameCXHL2301054 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 SIR2446M片 · No verified English nameCXHL2301053 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2023/10/09New drug · Class 1 NH300231肠溶片 · No verified English nameCXHL2301052 Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized

21 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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