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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 310 drug applications between 10 June 2024 and 16 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.

2024/06/10 – 2024/06/16

Period
2024/06/10 to 2024/06/16, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
3

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

310filings, 76 of them generic

By application type

Application typeFilings
Supplement157
Generic76
New drug50
Import12
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug218
TCM48
Therapeutic biologic37
Biologic5
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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Penicillin G Sodium For Injection512
2Amisulpride Injection321
3西甲硅油乳剂 · No verified English name223
4丁酸氯维地平注射用乳剂 · No verified English name210
5Tacrolimus Capsules212
6头孢呋辛酯干混悬剂 · No verified English name215
7Bisoprolol Fumarate Tablets216
8Ibuprofen Suspension2114
9Lacosamide Injection210
10Amikacin Sulfate injection214

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging S.P.A.2410
2Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized872
3Novartis Pharma Schweiz AG730
4Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized720
5Boehringer Ingelheim International GmbH710
6Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized660
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
8Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized530
9Xizang Jin Yue Pharmaceuticals Co., Ltd. romanized515
10Hainan Ai Ke Pharmaceutical Co., Ltd. romanized444

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

99 this week

AcceptedDrugApplicants
2024/06/15Import · Class 1 BAY 2927088片 · No verified English nameJXHL2400140 Bayer AG; Bayer Healthcare Company Ltd.
2024/06/15Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400139 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400138 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/06/15Import · Class 1 AZD9833片 · No verified English nameJXHL2400137 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2024/06/15Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2401808 Chengdu Tong De Pharma Co., Ltd. romanized
2024/06/15Generic · Class 3 Minoxidil LinimentCYHS2401807 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/06/15Generic · Class 3 Minoxidil LinimentCYHS2401806 Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/06/15Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401805 Sichuan Xin Tuo Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 3.1 五味消毒饮颗粒 · No verified English nameCXZS2400022 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400394 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400393 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 1 GR1802注射液 · No verified English nameCXSL2400392 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 1 GR1802注射液 · No verified English nameCXSL2400391 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2024/06/15New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2400390 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/14Import · Class 2.2 Efgartigimod注射液 · No verified English nameJXSL2400113 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2024/06/14Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401798 Nanjing Si Ling Pharmaceuticals Technology Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2024/06/14Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2401797 Ya Bao Pharma Group Co., Ltd. romanized
2024/06/14Generic · Class 3 Regadenoson InjectionCYHL2400112 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2024/06/14Generic · Class 3 Cetirizine Hydrochloride InjectionCYHL2400111 Zhong Fu Pharma Co., Ltd. romanized
2024/06/14New drug · Class 1.1 益智安脑颗粒 · No verified English nameCXZL2400033 Beijing Jing Shi Nao Li Technology Co., Ltd. romanized
2024/06/14New drug · Class 1 SCT520FF注射液 · No verified English nameCXSL2400389 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/14New drug · Class 1 SCT520FF注射液 · No verified English nameCXSL2400388 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/14New drug · Class 1 SCT520FF注射液 · No verified English nameCXSL2400387 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/14New drug · Class 3.3 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2400386 Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2024/06/14New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2400385 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/06/14New drug · Class 1 BN-1001眼用注射液 · No verified English nameCXSL2400384 Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized
2024/06/14New drug · Class 1 BN-1001眼用注射液 · No verified English nameCXSL2400383 Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized
2024/06/14New drug · Class 1 VV261片 · No verified English nameCXHL2400604 Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized
2024/06/14New drug · Class 1 VV261片 · No verified English nameCXHL2400603 Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized
2024/06/14New drug · Class 1 VV261片 · No verified English nameCXHL2400602 Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized

69 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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