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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 444 drug applications between 9 July 2026 and 15 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 47 drug names.

2026/07/09 – 2026/07/15

Period
2026/07/09 to 2026/07/15, 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
444
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
132

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

444filings, 58 of them generic

By application type

Application typeFilings
Supplement270
Generic58
New drug55
Unspecified26
Import26
Import re-registration9

By drug type

Drug typeFilings
Chemical drug214
TCM146
Therapeutic biologic72
Biologic8
Prophylactic biologic4

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ethyl Iosapentate Capsules3227
2氧 · No verified English name2215
3瑞维那新吸入溶液 · No verified English name2253
4Oxaliplatin Injection214
5Cefuroxime Sodium for Injection218
6Hydrocortisone Sodium Succinate for Injection2116
7甲苯磺酸卢美哌隆胶囊 · No verified English name212
8Bromhexine Hydrochloride Oral Solution2122
9Minoxidil Liniment2152
10Estradiol Gel218

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

272 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Ao Er Pharma Co., Ltd. romanized990
2Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized870
3Pfizer Inc.810
4Novo Nordisk A/S720
5Amgen Inc.610
6Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized610
7Shanxi Huang He Zhong Yao Co., Ltd. romanized550
8Topfond Pharmaceutical Co., Ltd.540
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD532
10Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized520

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

110 this week

AcceptedDrugApplicants
2026/07/15Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2600165 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600276 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600275 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600274 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600273 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Generic · Class 3 Oxaliplatin InjectionCYHS2601692 Hefei Li Cheng Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 Oxaliplatin InjectionCYHS2601691 Hefei Li Cheng Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2601688 Anhui Mei Lai Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2601687 Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized
2026/07/15Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHS2601686 Jiangsu En Hua Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHS2601685 Jiangsu En Hua Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 左氧氟沙星滴耳液 · No verified English nameCYHS2601683 Hefei Li Min Pharmaceutical Co., Ltd. romanized
2026/07/15Generic · Class 3 尿素[13C]片呼气试验药盒 · No verified English nameCYHL2600080 Beijing Hua Gen An Bang Technology Co., Ltd. romanized
2026/07/15New drug · Class 1.1 ZYY-757颗粒 · No verified English nameCXZL2600061 Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized
2026/07/15New drug · Class 1 JL4031胶囊 · No verified English nameCXHL2600856 Sichuan Jian Lin Pharma Co., Ltd. romanized; Zhongguo Ren Min Jie Fang Jun Kong Jun Jun Yi University Di Er Fu Shu Hospital romanized
2026/07/15New drug · Class 1 JL4031胶囊 · No verified English nameCXHL2600855 Sichuan Jian Lin Pharma Co., Ltd. romanized; Zhongguo Ren Min Jie Fang Jun Kong Jun Jun Yi University Di Er Fu Shu Hospital romanized
2026/07/15New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600854 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/07/15New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600853 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/07/14Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2600164 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/14Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2600163 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/14Generic · Class 3 Mepivacaine Hydrochloride InjectionCYHS2601677 Guangdong Sunho Pharmaceutical Co., Ltd.
2026/07/14Generic · Class 3 Minoxidil LinimentCYHS2601676 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/07/14Generic · Class 3 Minoxidil LinimentCYHS2601675 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/07/14New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2600737 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/07/14New drug · Class 1 TQB2922注射液(皮下注射) · No verified English nameCXSL2600736 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/07/14New drug · Class 1 HRS-4729注射液 · No verified English nameCXHL2600852 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 HRS-4729注射液 · No verified English nameCXHL2600851 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2600850 Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized
2026/07/14New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2600849 Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized
2026/07/14New drug · Class 2.3 BTP0427 · No verified English nameCXHL2600848 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized

80 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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