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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 17 August 2024 and 23 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 69 drug names.

2024/08/17 – 2024/08/23

Period
2024/08/17 to 2024/08/23, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
69
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

301filings, 97 of them generic

By application type

Application typeFilings
Supplement132
Generic97
New drug35
Unspecified24
Import re-registration8
Import5

By drug type

Drug typeFilings
Chemical drug189
TCM64
Therapeutic biologic33
Biologic12
Prophylactic biologic3

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nicardipine Hydrochloride Injection4213
2Ambroxol Hydrochloride Oral Solution3246
3Riociguat Tablets314
4Vonoprazan Fumarate Tablets2260
5Dapoxetine Hydrochloride Tablets2220
6Sodium Bicarbonate Injection2210
7Lactulose Oral Solution2134
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

202 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1010
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
3Guangxi Chan Fang Pharma Co., Ltd. romanized440
4Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized430
5Hubei Mei Lin Pharma Co., Ltd. romanized420
6Janssen Research & Development LLC410
7Shenyang Hong Yao Group Co., Ltd. romanized330
8Xu Bi Di Pharma (Hebei) Co., Ltd. romanized333
9Guizhou Xin Bang Pharmaceutical Co., Ltd. romanized330
10Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized320

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

79 this week

AcceptedDrugApplicants
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400153 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400152 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400151 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Import · Class 2.1 Amivantamab注射液(皮下注射) · No verified English nameJXSL2400150 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/23Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2402759 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402756 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/23Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402755 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/23Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2402754 Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2402753 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/08/23Generic · Class 3 Lidocaine Hydrochloride Ophthalmic GelCYHL2400175 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/08/23Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHL2400174 Bai Shan Technology (Hu Zhou) Co., Ltd. romanized
2024/08/23Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHL2400173 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/08/23Generic · Class 3 Ranolazine Prolonged-Release TabletsCYHL2400172 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/08/23New drug · Class 1.1 糖宁通络片 · No verified English nameCXZL2400047 Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized
2024/08/23New drug · Class 1 CM512注射液 · No verified English nameCXSL2400560 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/08/23New drug · Class 2.2 左乙拉西坦缓释颗粒 · No verified English nameCXHS2400081 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/23New drug · Class 2.2 BCM899颗粒 · No verified English nameCXHL2400858 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/08/23New drug · Class 2.2 BCM899颗粒 · No verified English nameCXHL2400857 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
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

49 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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