YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 460 drug applications between 12 September 2026 and 18 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 49 drug names.
2026/09/12 – 2026/09/18
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 394
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
460filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 247 |
| New drug | 109 |
| Generic | 72 |
| Import | 16 |
| Unspecified | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| TCM | 145 |
| Therapeutic biologic | 88 |
| Biologic | 4 |
| Prophylactic biologic | 2 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 4 | 1 | 27 |
| 2 | Emedastine Difumarate Sustained-release Capsules | 3 | 2 | 11 |
| 3 | 司美格鲁肽注射液 · No verified English name | 3 | 1 | 92 |
| 4 | 盐酸金刚烷胺口服溶液 · No verified English name | 3 | 1 | 3 |
| 5 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 6 | Polidocanol Injection | 3 | 1 | 23 |
| 7 | Mupirocin Ointment | 3 | 1 | 30 |
| 8 | Fruquintinib Capsules | 2 | 1 | 4 |
| 9 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 10 | Pioglitazone Hydrochloride Tablets | 2 | 1 | 2 |
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
266 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 10 | 7 | 0 |
| 2 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Novo Nordisk A/S | 6 | 2 | 0 |
| 6 | Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Novartis Pharma AG | 5 | 3 | 0 |
| 9 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 10 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 5 | 2 | 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
147 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/18Import · Class 1 | BMS-986446注射液 · No verified English nameJXSL2600250 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/09/18Generic · Class 3 | 右美沙芬缓释混悬液 · No verified English nameCYHS2602333 | Anhui Yuan Wang Le Huan Pharma Co., Ltd. romanized |
| 2026/09/18Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2602329 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2026/09/18Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2602328 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2026/09/18New drug · Class 1 | 注射用AK2405 · No verified English nameCXSL2601027 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | 注射用HB0085 · No verified English nameCXSL2601026 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2601025 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2601024 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | 注射用MBS314 · No verified English nameCXSL2601023 | Kang Yuan Bo Chuang Bio Technology (Beijing) Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | LY3839056注射液 · No verified English nameCXSL2601022 | Li Lai (Zhongguo) Research and Development Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | NC001细胞注射液 · No verified English nameCXSL2601021 | Zhejiang Tian Yu Sheng Ming Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | ACC085片 · No verified English nameCXHL2601178 | Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Lu Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | ACC085片 · No verified English nameCXHL2601177 | Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Lu Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | FXS0260片 · No verified English nameCXHL2601176 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | FXS0260片 · No verified English nameCXHL2601175 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | FXS0260片 · No verified English nameCXHL2601174 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | IPG7236片 · No verified English nameCXHL2601173 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | IPG7236片 · No verified English nameCXHL2601172 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | YM-101滴眼液 · No verified English nameCXHL2601171 | Name not romanized |
| 2026/09/18New drug · Class 1 | YM-101滴眼液 · No verified English nameCXHL2601170 | Name not romanized |
| 2026/09/18New drug · Class 1 | YM-101滴眼液 · No verified English nameCXHL2601169 | Name not romanized |
| 2026/09/18New drug · Class 1 | Y-1注射液 · No verified English nameCXHL2601168 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2026/09/18New drug · Class 1 | Y-1注射液 · No verified English nameCXHL2601167 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2026/09/17Import · Class 1 | PF-08046876 · No verified English nameJXSL2600249 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/17Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2602313 | Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | IBI3043 · No verified English nameCXSL2601020 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.2 | 注射用波米泰酶α · No verified English nameCXSL2601019 | Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | ASP1002注射液 · No verified English nameCXSL2601018 | An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | ASP1002注射液 · No verified English nameCXSL2601017 | An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | 注射用HX111 · No verified English nameCXSL2601016 | Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
117 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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