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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 28 June 2024 and 4 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 73 drug names.

2024/06/28 – 2024/07/04

Period
2024/06/28 to 2024/07/04, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
8

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

370filings, 98 of them generic

By application type

Application typeFilings
Supplement198
Generic98
New drug40
Import17
Import re-registration12
Unspecified5

By drug type

Drug typeFilings
Chemical drug276
TCM49
Therapeutic biologic38
Prophylactic biologic7

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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Epalrestat Tablets331
2Bumetanide Injection3213
3地氯雷他定口服溶液 · No verified English name3126
4Vortioxetine Hydrobromide Tablets2210
5盐酸阿莫罗芬搽剂 · No verified English name2215
6维生素B12滴眼液 · No verified English name222
7维生素B6注射液 · No verified English name2210
8Ipratropium Bromide Inhalation Solution212
9Diquafosol Sodium Eye Drops215
10复方醋酸钠林格注射液 · No verified English name212

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Luo Yang Hao Long Pharma Co., Ltd. romanized1780
2Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized10100
3Ha Yao Group Pharmaceutical Factory romanized640
4AstraZeneca AB630
5Janssen Research & Development LLC620
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Shanxi Hua Kang Pharma Co., Ltd. romanized430
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized431
9Ren He Yi Kang Group Co., Ltd. romanized422
10Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized410

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
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400159 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400158 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Bleximenib胶囊 · No verified English nameJXHL2400157 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/04Import · Class 1 Dexpramipexole片 · No verified English nameJXHL2400156 Areteia Therapeutics Inc.; Parexel China Co Ltd.
2024/07/04Import · Class 1 Dexpramipexole片 · No verified English nameJXHL2400155 Areteia Therapeutics Inc.; Parexel China Co Ltd.
2024/07/04Generic · Class 3 Epalrestat TabletsCYHS2402025 Anhui Pioneer Pharmaceutical Co., Ltd
2024/07/04Generic · Class 3 Pentoxifylline InjectionCYHS2402024 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2402023 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2402022 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/07/04Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2402019 Guizhou Bo Lin Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402018 Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2402017 CISEN PHARMACEUTICAL CO., LTD.
2024/07/04Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2402016 CISEN PHARMACEUTICAL CO., LTD.
2024/07/04Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402015 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2024/07/04Generic · Class 3 Acetylcysteine InjectionCYHS2402010 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2024/07/04Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402009 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/07/04Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402008 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/07/04Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402007 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/07/04New drug · Class 3.1 易黄颗粒 · No verified English nameCXZS2400025 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/07/04New drug · Class 3.3 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母) · No verified English nameCXSS2400063 Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/07/04New drug · Class 1 KL-A167注射液 · No verified English nameCXSL2400426 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/07/04New drug · Class 1 注射用SKB264 · No verified English nameCXSL2400425 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/07/04New drug · Class 1 RJK-RT2831注射液 · No verified English nameCXSL2400424 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2024/07/04New drug · Class 1 ABSK043胶囊 · No verified English nameCXHL2400655 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/07/04New drug · Class 1 50561片 · No verified English nameCXHL2400654 Beijing Zhuo Kai Bio Technology Co., Ltd. romanized
2024/07/04New drug · Class 2.4 优替德隆注射液 · No verified English nameCXHL2400653 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized
2024/07/04New drug · Class 1 HRS-2129片 · No verified English nameCXHL2400652 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/07/04New drug · Class 1 HRS-2129片 · No verified English nameCXHL2400651 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/07/04New drug · Class 2.2; 2.4 磷酸氯喹凝胶 · No verified English nameCXHL2400650 Guangzhou Kai Pu Bio Technology Co., Ltd. romanized
2024/07/04New drug · Class 2.2; 2.4 磷酸氯喹凝胶 · No verified English nameCXHL2400649 Guangzhou Kai Pu Bio Technology 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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