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
- 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 type | Filings |
|---|---|
| Supplement | 240 |
| New drug | 72 |
| Generic | 61 |
| Import | 43 |
| Import re-registration | 9 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 139 |
| Therapeutic biologic | 86 |
| Prophylactic biologic | 3 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二硫化硒洗剂 · No verified English name | 3 | 2 | 14 |
| 2 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 3 | Rotigotine Patches | 3 | 1 | 7 |
| 4 | Lactulose Oral Solution | 2 | 1 | 34 |
| 5 | Eplerenone Tablets | 2 | 1 | 4 |
| 6 | Empagliflozin Tablets | 2 | 1 | 18 |
| 7 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 8 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 9 | 甘油灌肠剂 · No verified English name | 2 | 1 | 2 |
| 10 | Metformin Hydrochloride Tablets | 2 | 1 | 4 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | F. Hoffmann-La Roche Ltd | 10 | 2 | 0 |
| 2 | Eli Lilly and Company | 9 | 3 | 0 |
| 3 | AbbVie Inc. | 9 | 2 | 0 |
| 4 | Novo Nordisk A/S | 9 | 2 | 0 |
| 5 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 6 | Pfizer Inc. | 7 | 4 | 0 |
| 7 | Novartis Pharma AG | 6 | 4 | 0 |
| 8 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | San Men Xia Guang Yu Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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