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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 428 drug applications between 27 August 2026 and 2 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 44 drug names.

2026/08/27 – 2026/09/02

Period
2026/08/27 to 2026/09/02, 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)
44
Accepted this week, now under review
300

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, 61 of them generic

By application type

Application typeFilings
Supplement240
New drug72
Generic61
Import43
Import re-registration9
Unspecified3

By drug type

Drug typeFilings
Chemical drug200
TCM139
Therapeutic biologic86
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

44 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

240 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1F. Hoffmann-La Roche Ltd1020
2Eli Lilly and Company930
3AbbVie Inc.920
4Novo Nordisk A/S920
5Gan Li Pharma Shandong Co., Ltd. romanized810
6Pfizer Inc.740
7Novartis Pharma AG640
8Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized550
9Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized550
10San Men Xia Guang Yu Biopharmaceutical Co., Ltd. romanized440

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

134 this week

AcceptedDrugApplicants
2026/09/02Import · Class 3.1 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600087 Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd.
2026/09/02Import · Class 3.1 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600086 Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd.
2026/09/02Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSS2600085 CKD Bio Corporation
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600391 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600390 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600389 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600388 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600387 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600386 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600385 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600384 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 NVL-655片 · No verified English nameJXHL2600383 Nuvalent Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/09/02Import · Class 1 NVL-655片 · No verified English nameJXHL2600382 Nuvalent Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/09/02Generic · Class 3 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2602193 Hebei Tian Cheng Pharma Co., Ltd. romanized
2026/09/02Generic · Class 3 多种微量元素注射液(Ⅰ) · No verified English nameCYHS2602187 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized
2026/09/02New drug · Class 2.3 四磨汤口服液 · No verified English nameCXZL2600084 Hunan Han Sen Pharmaceutical Co., Ltd. romanized
2026/09/02New drug · Class 1 卓托奇拜单抗注射液 · No verified English nameCXSS2600144 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600143 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600142 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600141 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600140 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600139 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600138 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600137 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 博凡格鲁肽注射液 · No verified English nameCXSS2600136 Gan Li Pharma Shandong Co., Ltd. romanized
2026/09/02New drug · Class 1 注射用依康坦博妥塔单抗 · No verified English nameCXSS2600135 Shanghai Yi Lian Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/09/02New drug · Class 1 注射用HS-20093 · No verified English nameCXSS2600134 Changzhou Heng Bang Pharma Co., Ltd. romanized; Name not romanized
2026/09/02New drug · Class 1 QLS2416注射液 · No verified English nameCXSL2600953 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/09/02New drug · Class 1 注射用HLX105 · No verified English nameCXSL2600952 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/09/02New drug · Class 1 HS-20117-2注射液 · No verified English nameCXSL2600951 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized

104 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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