YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 425 drug applications between 9 August 2024 and 15 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 133, covering 82 drug names.

2024/08/09 – 2024/08/15

Period
2024/08/09 to 2024/08/15, 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
425
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
3

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

425filings, 133 of them generic

By application type

Application typeFilings
Supplement190
Generic133
New drug77
Import re-registration11
Import8
Unspecified6

By drug type

Drug typeFilings
Chemical drug303
TCM62
Therapeutic biologic45
Prophylactic biologic13
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1生理氯化钠溶液 · No verified English name5117
2Bisoprolol Fumarate and Amlodipine Besylate Tablets449
3Dapoxetine Hydrochloride Tablets4220
4Ketorolac Tromethamine Injection424
5Sacubitril Valsartan Sodium Tablets3170
6Cefoperazone Sodium and Sulbactam Sodium for Injection3114
7甲磺酸多沙唑嗪片 · No verified English name310
8Metformin Hydrochloride Extended-release Tablets3110
9Labetalol Hydrochloride Injection314
10Ibrutinib Capsules229

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

243 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1NAPP PHARMACEUTICALS LIMITED910
2Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
3Shanxi Hua Kang Pharma Co., Ltd. romanized640
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD640
5Henan Hua Feng Pharmaceutical Co., Ltd. romanized630
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
7Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized550
8Sichuan Kelun Pharmaceutical Co., Ltd.534
9Takeda Manufacturing Austria AG520
10Hebei Dao En Pharma Co., Ltd. romanized515

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

143 this week

AcceptedDrugApplicants
2024/08/15Generic · Class 3 Epalrestat TabletsCYHS2402661 Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized
2024/08/15Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2402658 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2024/08/15Generic · Class 3 Lidocaine Hydrochloride GelCYHS2402656 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2024/08/15Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2402653 Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2024/08/15Generic · Class 3 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402650 An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized
2024/08/15Generic · Class 3 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402649 An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized
2024/08/15Generic · Class 3 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402648 An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized
2024/08/15Generic · Class 3 Epalrestat TabletsCYHS2402647 Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized
2024/08/15New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400543 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/08/15New drug · Class 1 RC198注射液 · No verified English nameCXSL2400542 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/08/15New drug · Class 2.2 DT-PR2215 · No verified English nameCXHL2400837 Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2024/08/15New drug · Class 2.2 DT-PR2215 · No verified English nameCXHL2400836 Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2024/08/15New drug · Class 2.2 DT-PR2215 · No verified English nameCXHL2400835 Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized
2024/08/15New drug · Class 1 ARD-885片 · No verified English nameCXHL2400834 Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized
2024/08/15New drug · Class 1 ARD-885片 · No verified English nameCXHL2400833 Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized
2024/08/15New drug · Class 1 NTB-3119M片 · No verified English nameCXHL2400832 Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized
2024/08/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402644 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/08/14Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2402643 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/08/14Generic · Class 3 Furosemide InjectionCYHS2402642 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/08/14Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2402638 Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2024/08/14Generic · Class 3 Progesterone InjectionCYHS2402629 Anhui Chang Jiang Pharma Co., Ltd. romanized
2024/08/14Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402628 Anhui Pioneer Pharmaceutical Co., Ltd
2024/08/14Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402625 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/08/14Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402624 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/08/14New drug · Class 1 XKH001注射液 · No verified English nameCXSL2400541 Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/14New drug · Class 1 JCXH-211注射液 · No verified English nameCXSL2400540 Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400831 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400830 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400829 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2400828 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

113 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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