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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 30 August 2024 and 5 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 81 drug names.

2024/08/30 – 2024/09/05

Period
2024/08/30 to 2024/09/05, 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)
81
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, 115 of them generic

By application type

Application typeFilings
Supplement148
Generic115
New drug55
Import21
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug238
TCM61
Therapeutic biologic47
Prophylactic biologic6

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

81 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets5223
2Rivaroxaban Tablets413
3氯化钙注射液 · No verified English name336
4维生素B6注射液 · No verified English name3310
5Dapoxetine Hydrochloride Tablets3220
6Gadobutrol Injection318
7中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name227
8Formoterol Fumarate Inhalation Solution225
9Nicardipine Hydrochloride Injection2213
10Glucosamine Sulfate Capsules2251

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
1Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized11110
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized990
3Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized535
4AstraZeneca AB520
5Jiangsu Kang Yuan Pharma Co., Ltd. romanized520
6Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized444
7Qingdao Dong Hai Pharma Co., Ltd. romanized440
8Janssen-Cilag International NV420
9Novartis Pharma Schweiz AG420
10ASPEN PHARMA TRADING LIMITED410

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

108 this week

AcceptedDrugApplicants
2024/09/05Import · Class 3.1 帕西生长素注射液 · No verified English nameJXSS2400074 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/09/05Import · Class 3.1 帕西生长素注射液 · No verified English nameJXSS2400073 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/09/05Import · Class 2.2 格菲妥单抗注射液 · No verified English nameJXSS2400072 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2024/09/05Import · Class 1 AZD0486 · No verified English nameJXSL2400163 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/05Import · Class 1 AZD0486 · No verified English nameJXSL2400162 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/05Import · Class 2.4 盐酸伊普可泮胶囊 · No verified English nameJXHS2400061 Novartis Pharma Schweiz AG; Novartis Pharma Produktions GmbH
2024/09/05Generic · Class 3 Carbazochrome Sodium Sulfonate TabletsCYHS2402929 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/09/05Generic · Class 3 Carbazochrome Sodium Sulfonate TabletsCYHS2402928 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/09/05Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402925 Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2024/09/05Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2402919 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/09/05Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2402915 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/05New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2400595 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/09/05New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2400594 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/05New drug · Class 1 注射用SHR-1501 · No verified English nameCXSL2400593 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/05New drug · Class 1 注射用MHB118C · No verified English nameCXSL2400592 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/09/05New drug · Class 1 注射用SKB571 · No verified English nameCXSL2400591 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/09/05New drug · Class 1 硫酸艾玛昔替尼片 · No verified English nameCXHS2400089 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/05New drug · Class 1 PE-003片 · No verified English nameCXHL2400912 Yuan Yan Gang Sheng Ming Ke Xue (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized
2024/09/05New drug · Class 1 PE-003片 · No verified English nameCXHL2400911 Yuan Yan Gang Sheng Ming Ke Xue (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized
2024/09/05New drug · Class 1 伊匹乌肽滴眼液 · No verified English nameCXHL2400910 Guangzhou Yi Ming Kang Bio Technology Co., Ltd. romanized
2024/09/05New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2400909 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/09/04Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2400071 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2024/09/04Import · Class 1 BI 765179 注射用粉末 · No verified English nameJXSL2400161 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400160 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400159 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD8630 · No verified English nameJXSL2400158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2400157 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/09/04Import · Class 2.4 Atogepant Tablets · No verified English nameJXHL2400215 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/09/04Import · Class 1 AZD5004薄膜包衣片 · No verified English nameJXHL2400214 Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/04Import · Class 1 AZD5004薄膜包衣片 · No verified English nameJXHL2400213 Eccogene Inc.; AstraZeneca Global R&D (China) Co. Ltd.

78 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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