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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 290 drug applications between 15 August 2024 and 21 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 68 drug names.

2024/08/15 – 2024/08/21

Period
2024/08/15 to 2024/08/21, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
5

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

290filings, 93 of them generic

By application type

Application typeFilings
Supplement129
Generic93
New drug43
Unspecified13
Import11
Import re-registration1

By drug type

Drug typeFilings
Chemical drug189
TCM58
Therapeutic biologic33
Biologic8
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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1甲磺酸多沙唑嗪片 · No verified English name310
2Nicardipine Hydrochloride Injection3113
3Epalrestat Tablets221
4Bisoprolol Fumarate and Amlodipine Besylate Tablets229
5Sodium Bicarbonate Injection2210
6Lactulose Oral Solution2134
7依伏卡塞片 · No verified English name219
8Sodium Picosulfate Oral Solution210
9Sodium Tetradecyl Sulphate Injection210
10Diclofenac Sodium Sustained Release Tablets2110

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan San Xue Pharma Co., Ltd. romanized630
2Novartis Pharma AG620
3Novo Nordisk A/S510
4Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized440
5Guangxi Chan Fang Pharma Co., Ltd. romanized440
6Janssen Research & Development LLC420
7Hubei Mei Lin Pharma Co., Ltd. romanized420
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
9Jiangsu Shen Hua Pharma Co., Ltd. romanized330
10Guizhou Xin Bang Pharmaceutical Co., Ltd. romanized330

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
2024/08/21Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402732 Zhejiang Le Pu Pharmaceutical Co., Ltd. romanized
2024/08/21Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2402725 Anhui Pioneer Pharmaceutical Co., Ltd; Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized
2024/08/21Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2402724 Anhui Pioneer Pharmaceutical Co., Ltd; Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized
2024/08/21Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2402722 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized
2024/08/21Generic · Class 3 Amifostine For InjectionCYHS2402719 Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/08/21Generic · Class 3 Fat-Soluble Vitamin Injection(Ⅱ)CYHS2402718 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/08/21Generic · Class 3 Potassium Chloride Oral SolutionCYHS2402716 Nanjing Hai Jing Pharma Co., Ltd. romanized
2024/08/21Generic · Class 3 Sodium Picosulfate Oral SolutionCYHL2400171 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized
2024/08/21Generic · Class 3 Sodium Picosulfate Oral SolutionCYHL2400170 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized
2024/08/21New drug · Class 1 GZL-016注射液 · No verified English nameCXSL2400556 Guangzhou Lai En Biopharmaceuticals Co., Ltd. romanized
2024/08/21New drug · Class 2.4 奥布替尼片 · No verified English nameCXHS2400078 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2024/08/21New drug · Class 1 注射用RAB001 · No verified English nameCXHL2400853 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized
2024/08/21New drug · Class 2.2 BCM684口崩片 · No verified English nameCXHL2400852 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/08/20Generic · Class 3 Oxacillin Sodium for InjectionCYHS2402712 Shandong Lukang Pharmaceutical Co.,Ltd.
2024/08/20Generic · Class 3 Oxacillin Sodium for InjectionCYHS2402711 Shandong Lukang Pharmaceutical Co.,Ltd.
2024/08/20Generic · Class 3 Potassium Chloride InjectionCYHS2402710 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 Sodium Bicarbonate InjectionCYHS2402706 Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402705 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2402704 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2402699 Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 Sodium Bicarbonate InjectionCYHS2402696 Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/08/20Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2402692 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/08/20Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2400169 Chengdu Ao Bang Pharma Co., Ltd. romanized
2024/08/20Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2400168 Chengdu Ao Bang Pharma Co., Ltd. romanized
2024/08/20New drug · Class 1 注射用芦康沙妥珠单抗 · No verified English nameCXSS2400087 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/08/20New drug · Class 3.4 帕尼单抗注射液 · No verified English nameCXSS2400086 Qilu Pharmaceutical Co., Ltd.
2024/08/20New drug · Class 1 CVL006 注射液 · No verified English nameCXSL2400555 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized
2024/08/20New drug · Class 1 IBI115 · No verified English nameCXSL2400554 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/20New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHS2400077 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2024/08/20New drug · Class 1 洛布替尼片 · No verified English nameCXHL2400851 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized

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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