YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 428 drug applications between 7 October 2024 and 13 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 86 drug names.

2024/10/07 – 2024/10/13

Period
2024/10/07 to 2024/10/13, 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
428
Drugs with new generic filings (by drug name, de-duplicated)
86
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

428filings, 118 of them generic

By application type

Application typeFilings
Supplement197
Generic118
New drug57
Import31
Unspecified13
Import re-registration12

By drug type

Drug typeFilings
Chemical drug295
TCM68
Therapeutic biologic59
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

86 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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bristol-Myers Squibb Pharma EEIG1140
2Guizhou Ke Lun Pharma Co., Ltd. romanized931
3Janssen-Cilag International NV860
4Bard Pharmaceuticals Limited660
5Jiangsu Shen Hua Pharma Co., Ltd. romanized550
6AstraZeneca AB540
7Merck Sharp & Dohme B.V.530
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
9Eli Lilly and Company520
10Bai Ji Shen Zhou (Suzhou) Bio Technology 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

123 this week

AcceptedDrugApplicants
2024/10/13Import · Class 3.1 伊匹木单抗注射液 · No verified English nameJXSS2400093 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 伊匹木单抗注射液 · No verified English nameJXSS2400092 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2400091 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2400090 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/10/13Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2403448 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/10/13Generic · Class 3 Furosemide TabletsCYHS2403447 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2403446 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2403445 Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 Bepotastine Besilate Orally Disintegrating TabletsCYHS2403441 Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403434 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 Enalapril Maleate Oral SolutionCYHS2403433 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2024/10/13Generic · Class 3 Indocyaninegreen for InjectionCYHS2403430 Beijing Shu Zi Jing Zhun Medical Technology Co., Ltd. romanized; Yue Kang Pharma Group Co., Ltd. romanized
2024/10/13New drug · Class 1 SYS6005 · No verified English nameCXSL2400692 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/10/13New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2400105 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/10/13New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2400104 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/10/13New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHS2400103 Shenzhen Han Yu Pharma Co., Ltd. romanized
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

93 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.