YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 397 drug applications between 17 June 2026 and 23 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 32 drug names.

2026/06/17 – 2026/06/23

Period
2026/06/17 to 2026/06/23, 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
397
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
107

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

397filings, 49 of them generic

By application type

Application typeFilings
Supplement277
Generic49
New drug48
Import15
Unspecified6
Import re-registration2

By drug type

Drug typeFilings
TCM180
Chemical drug148
Therapeutic biologic63
Prophylactic biologic5
Biologic1

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

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Mei Hua Yi (Hebei) Pharmaceutical Co., Ltd. romanized990
2Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized980
3Novo Nordisk A/S820
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized770
5Dong E E Jiao Co., Ltd. romanized660
6Shanxi Hua Kang Pharma Co., Ltd. romanized660
7Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized660
8AstraZeneca AB540
9Zhejiang Wo Wu Bio Technology Co., Ltd. romanized510
10Haerbin Zhen Bao Pharmaceutical 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

89 this week

AcceptedDrugApplicants
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
2026/06/23Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601464 Beijing Sai Sheng Pharma Co., Ltd. romanized
2026/06/23New drug · Class 1 VGR-R01 · No verified English nameCXSS2600097 Shanghai Tai Chang Bio Technology Co., Ltd. romanized
2026/06/23New drug · Class 1 注射用维特柯妥拜单抗 · No verified English nameCXSS2600096 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Name not romanized
2026/06/23New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600662 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/23New drug · Class 1 注射用BLB101 · No verified English nameCXSL2600661 Jiangsu Bei Lian Bio Technology Co., Ltd. romanized
2026/06/23New drug · Class 1 HE006片 · No verified English nameCXHL2600751 Nanchang Hong Yi Pharma Co., Ltd. romanized
2026/06/23New drug · Class 1 HE006片 · No verified English nameCXHL2600750 Nanchang Hong Yi Pharma Co., Ltd. romanized
2026/06/23New drug · Class 1 吸入用BD77 · No verified English nameCXHL2600749 Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized
2026/06/23New drug · Class 1 177Lu-JLT003注射液 · No verified English nameCXHL2600748 Beijing Ji Lun Tai Pharmaceuticals Co., Ltd. romanized
2026/06/23New drug · Class 1 BST01散 · No verified English nameCXHL2600747 Shenzhen Ding Bang Bio Technology Co., Ltd. romanized
2026/06/23New drug · Class 1 EIK1001注射液 · No verified English nameCXHL2600746 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600071 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600070 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600069 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600068 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Generic · Class 3 Acetylcysteine TabletsCYHS2601460 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/06/22Generic · Class 3 Doxycycline Hyclate TabletsCYHS2601459 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/06/22New drug · Class 3.1 清金化痰汤颗粒 · No verified English nameCXZS2600032 Hunan Jiudian Pharmaceutical Co., Ltd
2026/06/22New drug · Class 1 注射用LYNC-101 · No verified English nameCXSL2600660 Ling Tai Tian Run Bio Technology (Shanghai) Co., Ltd. romanized

59 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.