YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 6 October 2024 and 12 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.

2024/10/06 – 2024/10/12

Period
2024/10/06 to 2024/10/12, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
2

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

352filings, 95 of them generic

By application type

Application typeFilings
Supplement155
Generic95
New drug53
Import26
Unspecified13
Import re-registration10

By drug type

Drug typeFilings
Chemical drug237
TCM58
Therapeutic biologic51
Biologic4
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

71 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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV750
2Bristol-Myers Squibb Pharma EEIG720
3Bard Pharmaceuticals Limited660
4Jiangsu Shen Hua Pharma Co., Ltd. romanized550
5AstraZeneca AB540
6Merck Sharp & Dohme B.V.530
7Eli Lilly and Company520
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Guizhou Ke Lun Pharma Co., Ltd. romanized521
10CISEN PHARMACEUTICAL CO., LTD.434

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

107 this week

AcceptedDrugApplicants
2024/10/12Import · Class 3.1 布西珠单抗注射液 · No verified English nameJXSS2400089 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2024/10/12Import · Class 3.1 布西珠单抗注射液 · No verified English nameJXSS2400088 Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd.
2024/10/12Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2400193 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2024/10/12Import · Class 1 HCB301注射液 · No verified English nameJXSL2400192 FBD Biologics Limited; Shanghai Hanchor Biotech Inc.
2024/10/12Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2400083 Eisai Europe Limited; Eisai Co. Ltd.
2024/10/12Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHS2400082 Eisai Europe Limited; Eisai Co. Ltd.
2024/10/12Generic · Class 3 Ampicillin Sodium For InjectionCYHS2403423 Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/10/12Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2403421 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/10/12Generic · Class 3 Cimetidine InjectionCYHS2403418 Da Li Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2403414 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2403412 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403411 Jiangsu Qian Ren Bio Technology Co., Ltd. romanized
2024/10/12Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403408 Jiangsu Qian Ren Bio Technology Co., Ltd. romanized
2024/10/12Generic · Class 3 Epalrestat TabletsCYHS2403407 Zhejiang Dong Ya Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2403406 Zhejiang Pu Li Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 Metoprolol Tartrate InjectionCYHS2403405 Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/10/12Generic · Class 3 Cytarabine InjectionCYHS2403404 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2024/10/12Generic · Class 3 Cytarabine InjectionCYHS2403402 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2024/10/12Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2403400 Nanjing Ai De Kai Teng Biopharmaceuticals Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2024/10/12Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2403394 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2024/10/12Generic · Class 3 Sodium Thiosulfate InjectionCYHS2403392 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2024/10/12Generic · Class 3 Potassium Chloride InjectionCYHS2403391 Heilongjiang Sheng Zhi Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/10/12New drug · Class 1.1 参黛直肠栓 · No verified English nameCXZL2400066 Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized
2024/10/12New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2400110 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized
2024/10/12New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2400109 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized
2024/10/12New drug · Class 1 注射用ILB-3101 · No verified English nameCXSL2400691 Ying Nuo Hu Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/10/12New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2400690 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/10/12New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2400689 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/10/12New drug · Class 1 注射用ZW25 · No verified English nameCXSL2400688 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/10/12New drug · Class 1 注射用SHR-9839 (sc) · No verified English nameCXSL2400687 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized

77 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.