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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 287 drug applications between 16 August 2024 and 22 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 67 drug names.

2024/08/16 – 2024/08/22

Period
2024/08/16 to 2024/08/22, 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
287
Drugs with new generic filings (by drug name, de-duplicated)
67
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

287filings, 91 of them generic

By application type

Application typeFilings
Supplement121
Generic91
New drug45
Unspecified18
Import11
Import re-registration1

By drug type

Drug typeFilings
Chemical drug189
TCM61
Therapeutic biologic29
Biologic7
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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets3260
2Ambroxol Hydrochloride Oral Solution3246
3Nicardipine Hydrochloride Injection3113
4Sodium Bicarbonate Injection2210
5Lactulose Oral Solution2134
6Sodium Picosulfate Oral Solution210
7Sodium Tetradecyl Sulphate Injection210
8Diclofenac Sodium Sustained Release Tablets2110
9Tropicamide Phenylephrine Eye Drops218
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

194 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novartis Pharma AG620
2Novo Nordisk A/S510
3Guangxi Chan Fang Pharma Co., Ltd. romanized440
4Hubei Mei Lin Pharma Co., Ltd. romanized420
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
6Shenyang Hong Yao Group Co., Ltd. romanized330
7Xu Bi Di Pharma (Hebei) Co., Ltd. romanized333
8Guizhou Xin Bang Pharmaceutical Co., Ltd. romanized330
9Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized330
10Anhui Pioneer Pharmaceutical Co., Ltd323

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
2024/08/22Generic · Class 3 Calcium Gluconate InjectionCYHS2402745 Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/08/22Generic · Class 3 Latamoxef Sodium for InjectionCYHS2402744 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2024/08/22Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402739 Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2024/08/22Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2402737 Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/08/22Generic · Class 3 Magnesium Sulfate InjectionCYHS2402736 Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/08/22Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2402734 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/08/22New drug · Class 2.3 血塞通软胶囊 · No verified English nameCXZL2400046 Kunming Hua Run Sheng Huo Pharma Co., Ltd. romanized
2024/08/22New drug · Class 1.1 九味癥消颗粒 · No verified English nameCXZL2400045 Zhongguo Zhong Yi Ke College Zhong Yi Lin Chuang Ji Chu Yi Xue Research Institute romanized
2024/08/22New drug · Class 1 CM512注射液 · No verified English nameCXSL2400559 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/08/22New drug · Class 1 CM512注射液 · No verified English nameCXSL2400558 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/08/22New drug · Class 1 艾米迈托赛注射液 · No verified English nameCXSL2400557 Bo Sheng Zhuo Yue Bio Technology (Beijing) Co., Ltd. romanized
2024/08/22New drug · Class 1 OB756片 · No verified English nameCXHS2400080 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2024/08/22New drug · Class 1 OB756片 · No verified English nameCXHS2400079 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2024/08/22New drug · Class 1 GD-20片 · No verified English nameCXHL2400856 Tianjin Gu Dui Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/22New drug · Class 2.2; 2.4 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2400855 Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized
2024/08/22New drug · Class 2.2; 2.4 盐酸戊乙奎醚吸入溶液 · No verified English nameCXHL2400854 Chongqing Xian Yang Pharmaceuticals Technology Co., Ltd. romanized
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.

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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