YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 45 drug applications between 30 September 2026 and 6 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 8, covering 7 drug names.
2026/09/30 – 2026/10/06
- New acceptances this week
- 45
- Drugs with new generic filings (by drug name, de-duplicated)
- 7
- Accepted this week, now under review
- 33
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
45filings, 8 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 24 |
| Generic | 8 |
| New drug | 8 |
| Import re-registration | 3 |
| Unspecified | 1 |
| Import | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 26 |
| TCM | 10 |
| Therapeutic biologic | 8 |
| Biologic | 1 |
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
7 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 2 | 1 | 55 |
| 2 | ω-3 Fish Oil Fat Emulsion Injection | 1 | 1 | 6 |
| 3 | Acetylcysteine Tablets | 1 | 1 | 8 |
| 4 | Sodium Ibandronate Injection | 1 | 1 | 4 |
| 5 | Levofloxacin Injection | 1 | 1 | 1 |
| 6 | 氧(液态) · No verified English name | 1 | 1 | 13 |
| 7 | Tranexamic Acid Tablets | 1 | 1 | 9 |
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
34 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Limited | 3 | 1 | 0 |
| 2 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 2 | 2 | 0 |
| 3 | Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized | 2 | 1 | 0 |
| 4 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 2 | 1 | 0 |
| 5 | NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 2 | 1 | 2 |
| 6 | Hangzhou Du Yi Technology Co., Ltd. romanized | 2 | 1 | 0 |
| 7 | Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 8 | Shenzhen Hua Run Jiu Chuang Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Chongqing Xing Chuang Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 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
11 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/30Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2600262 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/09/30Generic · Class 3 | Acetylcysteine TabletsCYHS2602434 | Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized |
| 2026/09/30Generic · Class 3 | Levofloxacin InjectionCYHS2602433 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | 注射用AST1001 · No verified English nameCXSL2601080 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | RG002-03注射液 · No verified English nameCXSL2601079 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2026/09/30New drug · Class 1 | ALXN2220注射液 · No verified English nameCXSL2601078 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SI-B037双特异性抗体注射液 · No verified English nameCXSL2601077 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/09/30New drug · Class 2.2; 2.4 | BTS1115 · No verified English nameCXHL2601220 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SPR2015片 · No verified English nameCXHL2601219 | Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | SPR2015片 · No verified English nameCXHL2601218 | Shanghai Si Pu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/30New drug · Class 1 | HJY-39注射液 · No verified English nameCXHL2601217 | Xiamen Gan Bao Li Biopharmaceuticals Co., Ltd. romanized |
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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