YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 3 July 2024 and 9 July 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 74 drug names.

2024/07/03 – 2024/07/09

Period
2024/07/03 to 2024/07/09, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
5

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

392filings, 106 of them generic

By application type

Application typeFilings
Supplement200
Generic106
New drug48
Import22
Import re-registration10
Unspecified6

By drug type

Drug typeFilings
Chemical drug270
TCM65
Therapeutic biologic49
Prophylactic biologic8

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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets5320
2Epalrestat Tablets331
3Vonoprazan Fumarate Tablets3260
4Minoxidil Liniment3252
5地氯雷他定口服溶液 · No verified English name3126
6Oxaliplatin Injection314
7Potassium Phosphates Injection222
8Vortioxetine Hydrobromide Tablets2210
9Nicardipine Hydrochloride Injection2213
10Acetylcysteine Granules214

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized1010
2Janssen Research & Development LLC930
3Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized880
4Pfizer Inc.640
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized640
6Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized550
7Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized535
8Bristol-Myers Squibb Pharma EEIG520
9Shenyang San Sheng Pharmaceutical Co., Ltd. romanized510
10Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized510

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

116 this week

AcceptedDrugApplicants
2024/07/09Import · Class 1 BAY 2862789片 · No verified English nameJXHL2400168 Bayer AG; Bayer Healthcare Company Ltd.
2024/07/09Import · Class 1 BAY 2862789片 · No verified English nameJXHL2400167 Bayer AG; Bayer Healthcare Company Ltd.
2024/07/09Generic · Class 3 Oxaliplatin InjectionCYHS2402086 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/09Generic · Class 3 Oxaliplatin InjectionCYHS2402085 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/09Generic · Class 3 Oxaliplatin InjectionCYHS2402084 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/09Generic · Class 3 Sodium Nitroprusside InjectionCYHS2402082 YaoPharma Co., Ltd.
2024/07/09Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402079 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/07/09Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402078 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/07/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2402071 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/07/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2402070 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/07/09Generic · Class 3 Sodium Thiosulfate InjectionCYHS2402069 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/07/09Generic · Class 3 Oxytocin InjectionCYHS2402068 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/07/09Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2402066 Shenyang Xin Ma Pharma Co., Ltd. romanized
2024/07/09Generic · Class 3 Ibuprofen and Phenylephrine Hydrochloride TabletsCYHL2400138 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2024/07/09Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2400137 Wuhan Ren Fu Pharma Co., Ltd. romanized
2024/07/09New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2400026 Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 注射用CMDE005 · No verified English nameCXSL2400438 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 TQH2722注射液 · No verified English nameCXSL2400437 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/07/09New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400436 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/07/09New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400051 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/07/09New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400050 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400674 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400673 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400672 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400671 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400670 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400669 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400668 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400667 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/07/09New drug · Class 1 ENC0653软膏 · No verified English nameCXHL2400666 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized

86 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.