YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 610 drug applications between 8 October 2026 and 14 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 120, covering 77 drug names.

2026/10/08 – 2026/10/14

Period
2026/10/08 to 2026/10/14, 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
610
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
546

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

610filings, 120 of them generic

By application type

Application typeFilings
Supplement308
Generic120
New drug119
Import33
Import re-registration18
Unspecified12

By drug type

Drug typeFilings
Chemical drug328
TCM159
Therapeutic biologic118
Biologic5

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

77 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

346 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11110
2Pfizer Inc.920
3Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized820
4N. V. Organon810
5Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized770
6Boehringer Ingelheim International GmbH710
7Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized640
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
9Upjohn Manufacturing Ireland Unlimited Company610
10Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized610

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

201 this week

AcceptedDrugApplicants
2026/10/14Import · Class 2.2 来瑞奇珠单抗注射液(皮下注射) · No verified English nameJXSS2600095 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/10/14Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2602547 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Ketoprofen PatchesCYHS2602542 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2026/10/14Generic · Class 3 Ketoprofen PatchesCYHS2602541 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized
2026/10/14Generic · Class 3 Propranolol hydrochloride oral solutionCYHS2602538 Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 米诺地尔泡沫剂(女用) · No verified English nameCYHS2602536 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2026/10/14Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2602528 Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2602527 Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Sodium Acetate Ringer's InjectionCYHS2602525 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Zolpidem tartrate extended-release tabletsCYHL2600117 Shandong Xin Yi Pharmaceutical Co., Ltd. romanized
2026/10/14Generic · Class 3 Zolpidem tartrate extended-release tabletsCYHL2600116 Shandong Xin Yi Pharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1.1 健脑通络颗粒 · No verified English nameCXZL2600099 Wuhan Bo Jin Tai Technology Co., Ltd. romanized
2026/10/14New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600163 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1 注射用BG-T0050 · No verified English nameCXSL2601124 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1 IBI324 · No verified English nameCXSL2601123 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/10/14New drug · Class 1 注射用重组E型肉毒毒素 · No verified English nameCXSL2601122 Hebei Feng Zhang Bio Technology Co., Ltd. romanized
2026/10/14New drug · Class 1 SYS6095注射液 · No verified English nameCXSL2601121 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/10/14New drug · Class 1 SYS6095注射液 · No verified English nameCXSL2601120 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/10/14New drug · Class 1 KYS202010A注射用冻干制剂 · No verified English nameCXSL2601119 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/10/14New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2601118 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2026/10/14New drug · Class 1 注射用BAT7112 · No verified English nameCXSL2601117 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2601116 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1 LK101注射液 · No verified English nameCXSL2601115 Beijing Li Kang Sheng Ming Technology Co., Ltd. romanized
2026/10/14New drug · Class 1 ACT001胶囊 · No verified English nameCXHL2601282 Shang De Yao Yuan (Tianjin) Biopharmaceutical Co., Ltd. romanized
2026/10/14New drug · Class 1 SYH2078注射液 · No verified English nameCXHL2601281 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2026/10/14New drug · Class 2.4 富马酸泰吉利定注射液 · No verified English nameCXHL2601280 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/10/14New drug · Class 2.4 富马酸泰吉利定注射液 · No verified English nameCXHL2601279 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/10/14New drug · Class 1 SIM0712胶囊 · No verified English nameCXHL2601278 Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2026/10/14New drug · Class 1 SIM0712胶囊 · No verified English nameCXHL2601277 Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized
2026/10/13Import · Class 3.1 尼塔奇单抗注射液(皮下注射) · No verified English nameJXSS2600094 Joint Stock Company “BIOCAD”(JSC “BIOCAD”); Gen8 (SH) Limited

171 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.