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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 14 August 2024 and 20 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 69 drug names.

2024/08/14 – 2024/08/20

Period
2024/08/14 to 2024/08/20, 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, 96 of them generic

By application type

Application typeFilings
Supplement133
Generic96
New drug48
Import13
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
Chemical drug195
TCM62
Therapeutic biologic37
Prophylactic biologic4
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
1Bisoprolol Fumarate and Amlodipine Besylate Tablets339
2Atorvastatin Calcium Tablets3224
3甲磺酸多沙唑嗪片 · No verified English name310
4Epalrestat Tablets221
5Eperisone Hydrochloride Tablets228
6Sodium Bicarbonate Injection2210
7依伏卡塞片 · No verified English name219
8Sodium Tetradecyl Sulphate Injection210
9Diclofenac Sodium Sustained Release Tablets2110
10Tropicamide Phenylephrine Eye Drops218

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novartis Pharma AG620
2Shanxi Hua Kang Pharma Co., Ltd. romanized530
3Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized440
4Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized440
5Guangxi Chan Fang Pharma Co., Ltd. romanized440
6BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED430
7Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized432
8Qilu Pharmaceutical Co., Ltd.431
9Janssen Research & Development LLC420
10Takeda Manufacturing Austria AG410

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

97 this week

AcceptedDrugApplicants
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
2024/08/20New drug · Class 1 洛布替尼片 · No verified English nameCXHL2400850 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2024/08/19New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2400553 Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized
2024/08/17Import · Class 1 AZD5492 · No verified English nameJXSL2400149 AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd.
2024/08/17Generic · Class 3 Bumetanide InjectionCYHS2402684 Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanized
2024/08/17Generic · Class 3 Sodium Tetradecyl Sulphate InjectionCYHL2400167 Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized
2024/08/17Generic · Class 3 Sodium Tetradecyl Sulphate InjectionCYHL2400166 Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized
2024/08/17Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400165 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/08/17New drug · Class 1 SYS6026注射液 · No verified English nameCXSL2400552 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/08/17New drug · Class 1 LAT010注射液 · No verified English nameCXSL2400551 Lai Te Kang (Suzhou) Biopharmaceutical Co., Ltd. romanized
2024/08/17New drug · Class 1 G01滴眼液 · No verified English nameCXSL2400550 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2024/08/17New drug · Class 1 G01滴眼液 · No verified English nameCXSL2400549 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2024/08/17New drug · Class 1 G01滴眼液 · No verified English nameCXSL2400548 Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized
2024/08/17New drug · Class 1 重组全人源抗PCSK9单克隆抗体注射液 · No verified English nameCXSL2400547 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

67 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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