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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 314 drug applications between 30 August 2023 and 5 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 74 drug names.

2023/08/30 – 2023/09/05

Period
2023/08/30 to 2023/09/05, 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
314
Drugs with new generic filings (by drug name, de-duplicated)
74
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

314filings, 101 of them generic

By application type

Application typeFilings
Supplement136
Generic101
New drug58
Import12
Import re-registration5
Unspecified2

By drug type

Drug typeFilings
Chemical drug219
TCM51
Therapeutic biologic36
Prophylactic biologic6
In vitro diagnostic reagent1
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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection442
2Nicorandil for Injection321
3Etoricoxib Tablets318
4Quetiapine Fumarate Tablets310
5Tadalafil Tablets2223
6Nicorandil Tablets224
7Pentoxifylline Injection223
8Potassium Chloride Injection2210
9Lornoxicam for Injection222
10腺苷钴胺胶囊 · No verified English name228

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

208 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Rui He Pharmaceutical Co., Ltd. romanized990
2Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized880
3Shenyang Hong Yao Group Co., Ltd. romanized430
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized430
5Rui Yang Pharmaceutical Co., Ltd. romanized420
6Organon Pharma (UK) Limited410
7Haikou Shi Pharmaceutical Factory Co., Ltd. romanized410
8Shenzhen Jia Ke Bio Technology Co., Ltd. romanized410
9CISEN PHARMACEUTICAL CO., LTD.410
10Jewim Pharmaceutical (Shandong) Co., Ltd.332

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

105 this week

AcceptedDrugApplicants
2023/09/05Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300076 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd.
2023/09/05Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300075 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd.
2023/09/05Import · Class 1 JDQ443片 · No verified English nameJXHL2300202 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2023/09/05Import · Class 1 DMX-200 · No verified English nameJXHL2300201 Dimerix Bioscience Pty Ltd; IQVIA RDS (Shanghai) Co. Ltd.
2023/09/05Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2302386 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2302385 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302378 Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2302377 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2302376 Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2023/09/05Generic · Class 3 美洛昔康纳米晶注射液 · No verified English nameCYHL2300112 Health Yuan Pharma Group Co., Ltd. romanized
2023/09/05New drug · Class 1.1 藿夏感冒颗粒 · No verified English nameCXZL2300059 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/09/05New drug · Class 1 舒西利单抗注射液 · No verified English nameCXSS2300072 Zhong Kang Biopharmaceutical (Haikou) Co., Ltd. romanized
2023/09/05New drug · Class 2.1 重组人CTLA-4变体Fc融合蛋白注射液 · No verified English nameCXSL2300600 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2023/09/05New drug · Class 1 HS-IT101注射液 · No verified English nameCXSL2300599 Qingdao Hua Sai Bo Man Yi Xue Xi Bao Bio Co., Ltd. romanized
2023/09/05New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2300598 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/05New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2300597 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/05New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2300596 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/09/05New drug · Class 1 WBC100胶囊 · No verified English nameCXHL2300954 Hangzhou Wei Ben Pharma Co., Ltd. romanized
2023/09/05New drug · Class 2.2 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2300953 Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2023/09/05New drug · Class 2.3 QLM2010 · No verified English nameCXHL2300952 Qilu Pharmaceutical Co., Ltd.
2023/09/05New drug · Class 1 TY705注射液 · No verified English nameCXHL2300951 Tianjin Drug Research Institute Co., Ltd. romanized
2023/09/05New drug · Class 1 TY705注射液 · No verified English nameCXHL2300950 Tianjin Drug Research Institute Co., Ltd. romanized
2023/09/05New drug · Class 1 JK0003片 · No verified English nameCXHL2300949 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2023/09/05New drug · Class 1 JK0003片 · No verified English nameCXHL2300948 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2023/09/05New drug · Class 1 JK0003片 · No verified English nameCXHL2300947 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2023/09/05New drug · Class 1 JK0003片 · No verified English nameCXHL2300946 Shenzhen Jia Ke Bio Technology Co., Ltd. romanized
2023/09/04Generic · Class 3 Pentoxifylline InjectionCYHS2302369 Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2023/09/02Generic · Class 3 Potassium Chloride InjectionCYHS2302366 Hainan Ou Ruo La Bio Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/09/02Generic · Class 3 Indobufen TabletsCYHS2302365 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized
2023/09/02Generic · Class 3 Indobufen TabletsCYHS2302364 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized

75 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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