YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 353 drug applications between 18 June 2026 and 24 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 32 drug names.

2026/06/18 – 2026/06/24

Period
2026/06/18 to 2026/06/24, 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
353
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
104

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

353filings, 47 of them generic

By application type

Application typeFilings
Supplement247
Generic47
New drug35
Import13
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
TCM160
Chemical drug131
Therapeutic biologic57
Biologic3
Prophylactic 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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection6338
2Fosfomycin Sodium For Injection3116
3Emedastine Difumarate Sustained-release Capsules2111
4Methylprednisolone Sodium Succinate for injection2112
5环硅酸锆钠散 · No verified English name2112
6Ioversol Injection219
7Minoxidil Liniment2152
8Mirogabalin Besilate Tablets2161
9Dapagliflozin Tablets2184
10马来酸左氨氯地平片 · No verified English name213

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized13120
2Dong E E Jiao Co., Ltd. romanized10100
3Novo Nordisk A/S1030
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized770
5AstraZeneca AB540
6Yi Chun Pharma Co., Ltd. romanized440
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized440
8Shenyang Dong Xin Pharma Co., Ltd. romanized440
9Shaanxi Hua Tai Pharma Co., Ltd. romanized440
10Heilongjiang Tian Long Pharma Co., Ltd. romanized440

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

67 this week

AcceptedDrugApplicants
2026/06/24Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2601486 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2026/06/24Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2601485 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2026/06/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2601484 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2026/06/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2601483 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2026/06/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2601481 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2026/06/24Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2601479 Tang Shan Li Kang Pharma Co., Ltd. romanized
2026/06/24New drug · Class 1 HB0017注射液 · No verified English nameCXSS2600100 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Zhejiang Hua Hai Bio Technology Co., Ltd. romanized
2026/06/24New drug · Class 3.4 破伤风人免疫球蛋白 · No verified English nameCXSS2600099 Zhengzhou Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized
2026/06/24New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSS2600098 Beijing Wan Tai Bio Pharma Co., Ltd. romanized
2026/06/24New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600670 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/06/24New drug · Class 1 SKB118注射液 · No verified English nameCXSL2600669 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/06/24New drug · Class 1 SCT650C 注射液 · No verified English nameCXSL2600668 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/24New drug · Class 1 TQB2922注射液(皮下注射) · No verified English nameCXSL2600667 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/06/24New drug · Class 1 注射用HS-20110 · No verified English nameCXSL2600666 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/06/24New drug · Class 1 HS-20117-2注射液 · No verified English nameCXSL2600665 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/06/24New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2600664 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2026/06/24New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2600663 Shanghai Bang Yao Biopharmaceuticals Co., Ltd. romanized
2026/06/24New drug · Class 2.2 BCM993 · No verified English nameCXHL2600753 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2026/06/24New drug · Class 2.4 左氧氟沙星雾化吸入溶液 · No verified English nameCXHL2600752 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized
2026/06/23Import · Class 1 AZD2287 · No verified English nameJXSL2600149 AstraZeneca AB; AstraZeneca Global R&D(China)Co. Ltd.
2026/06/23Import · Class 1 AZD2284 · No verified English nameJXSL2600148 AstraZeneca AB; AstraZeneca Global R&D(China)Co. Ltd.
2026/06/23Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2600147 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2026/06/23Import · Class 1 Laroprovstat瑞舒伐他汀片 · No verified English nameJXHL2600223 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/23Import · Class 1 Laroprovstat瑞舒伐他汀片 · No verified English nameJXHL2600222 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/23Generic · Class 3 Minoxidil LinimentCYHS2601475 Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
2026/06/23Generic · Class 3 Minoxidil LinimentCYHS2601474 Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
2026/06/23Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601470 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2026/06/23Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601469 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2026/06/23Generic · Class 3 左氧氟沙星滴耳液 · No verified English nameCYHS2601468 Wuhan Wu Jing Pharma Co., Ltd. romanized
2026/06/23Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601465 Beijing Sai Sheng Pharma Co., Ltd. romanized

37 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.