YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 251 drug applications between 4 October 2023 and 10 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 50 drug names.

2023/10/04 – 2023/10/10

Period
2023/10/04 to 2023/10/10, 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
251
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
0

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

251filings, 60 of them generic

By application type

Application typeFilings
Supplement113
Generic60
New drug46
Import re-registration14
Unspecified9
Import8
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug181
Therapeutic biologic35
TCM32
Prophylactic biologic3

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Clindamycin Phosphate Topical Solution211
2Lacosamide Tablets210
3昂丹司琼口溶膜 · No verified English name212
4Sacubitril Valsartan Sodium Tablets2170
5注射用头孢唑肟钠 · No verified English name214
6Sodium Hyaluronate Eye Drops2130
7Dapoxetine Hydrochloride Tablets2120
8Iopromide Injection2127
9Minoxidil Liniment2152
10Calcium Gluconate in Sodium Chloride Injection215

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

153 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD631
2Jiangsu En Hua Pharma Co., Ltd. romanized620
3Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized540
4Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized535
5Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized510
6Janssen-Cilag SpA420
7Sichuan Kelun Pharmaceutical Co., Ltd.422
8CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.421
9Eli Lilly Nederland B.V.410
10Sanofi-Aventis Deutschland GmbH410

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

76 this week

AcceptedDrugApplicants
2023/10/10Import · Class 1 巴托利单抗注射液 · No verified English nameJXSL2300175 DRAGON MERIT HOLDINGS LIMITED; CSPC Zhongqi Pharmaceutical Technology(Shijiazhuang). Ltd.
2023/10/10Import · Class 1 TIN816输注用粉末 · No verified English nameJXSL2300174 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/10Import · Class 1 Capivasertib片 · No verified English nameJXHS2300096 AstraZeneca UK Limited; AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/10/10Import · Class 1 Capivasertib片 · No verified English nameJXHS2300095 AstraZeneca UK Limited; AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/10/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302681 Jinan Tong Lu Pharmaceuticals Technology Development Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/10/10Generic · Class 3 Nicorandil for InjectionCYHS2302680 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hebei Ai Er Hai Tai Pharmaceutical Co., Ltd. romanized
2023/10/10Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2302671 Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized
2023/10/10Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2302670 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/10/10Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2302669 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/10/10Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2302668 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/10/10Generic · Class 3 复方聚乙二醇电解质散(3350) · No verified English nameCYHS2302667 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized
2023/10/10Generic · Class 3 Valsartan Oral SolutionCYHL2300127 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/10/10New drug · Class 1 注射用HC010 · No verified English nameCXSL2300679 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2023/10/10New drug · Class 1 SYHX1901片 · No verified English nameCXHL2301071 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/10/10New drug · Class 1 SYHX1901片 · No verified English nameCXHL2301070 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/10/10New drug · Class 1 SYHX1901片 · No verified English nameCXHL2301069 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/10/10New drug · Class 1 SYHX1901片 · No verified English nameCXHL2301068 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/10/10New drug · Class 1 HEC192334片 · No verified English nameCXHL2301067 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/10/10New drug · Class 1 HEC192334片 · No verified English nameCXHL2301066 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/10/10New drug · Class 1 HEC192334片 · No verified English nameCXHL2301065 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/10/10New drug · Class 2.3 SMF-210 · No verified English nameCXHL2301064 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/10/10New drug · Class 1 JMKX003142片 · No verified English nameCXHL2301063 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/10/10New drug · Class 1 JMKX003142片 · No verified English nameCXHL2301062 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/10/10New drug · Class 1 JMKX003142片 · No verified English nameCXHL2301061 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/10/10New drug · Class 1 HX-100101-1注射液 · No verified English nameCXHL2301060 Hong Xu Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized; Hong Xu Biopharmaceuticals Technology (Zhejiang) Co., Ltd. romanized
2023/10/09Import · Class 1 DS-1062a · No verified English nameJXSL2300173 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2023/10/09Import · Class 2.4 氯马昔巴特口服溶液 · No verified English nameJXHS2300094 Mirum Pharmaceuticals Inc.; Halo Pharmaceutical Canada Inc.; CANbridge (Suzhou) Bio-pharma Co. Ltd.
2023/10/09Generic · Class 3 Ebastine Oral SolutionCYHS2302665 Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302663 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/10/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2302661 Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized

46 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.

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