YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 21 September 2025 and 27 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 34 drug names.
2025/09/21 – 2025/09/27
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 53
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
279filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| New drug | 50 |
| Generic | 41 |
| Import | 20 |
| Unspecified | 8 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 151 |
| TCM | 72 |
| Therapeutic biologic | 51 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| Unspecified | 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 2 | Levocarnitine Oral Solution | 2 | 1 | 9 |
| 3 | 注射用氨苄西林钠舒巴坦钠/氯化钠注射液 · No verified English name | 2 | 1 | 2 |
| 4 | Atomoxetine Hydrochloride Capsules | 2 | 1 | 6 |
| 5 | Mometasone Furoate Cream | 2 | 1 | 16 |
| 6 | Polidocanol Injection | 2 | 1 | 23 |
| 7 | 醋酸锌片 · No verified English name | 2 | 1 | 3 |
| 8 | Acetylcysteine Injection | 1 | 1 | 53 |
| 9 | Crisaborole Ointment | 1 | 1 | 26 |
| 10 | Diclofenac Sodium Dual Release Enteric-coated Capsules | 1 | 1 | 3 |
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
168 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ke Lun Pharma Co., Ltd. romanized | 15 | 2 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 11 | 8 | 0 |
| 3 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Otsuka Pharmaceutical Co.,Ltd. | 6 | 1 | 0 |
| 5 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | pharmaand GmbH | 4 | 1 | 0 |
| 10 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized | 4 | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/26Import · Class 1 | AZD0486 · No verified English nameJXSL2500186 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/26Import · Class 1 | AZD0486 · No verified English nameJXSL2500185 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/26Import · Class 2.2 | 特泽利尤单抗注射液 · No verified English nameJXSL2500184 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/09/26Import · Class 2.4 | Fitusiran注射液 · No verified English nameJXHL2500300 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/09/26Import · Class 2.4 | Fitusiran注射液 · No verified English nameJXHL2500299 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/09/26Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503521 | Henan Hua Luo Kang Run Pharma Co., Ltd. romanized |
| 2025/09/26Generic · Class 3 | Indobufen TabletsCYHS2503519 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Henan Fu Sen Pharma Co., Ltd. romanized |
| 2025/09/26New drug · Class 1 | GB10注射液 · No verified English nameCXSL2500841 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2025/09/26New drug · Class 1 | N-3C01注射液 · No verified English nameCXSL2500834 | Hefei Xin Zhu Bio Technology Co., Ltd. romanized |
| 2025/09/26New drug · Class 1 | BSI-082注射液 · No verified English nameCXSL2500833 | Bo Ao Xin Bio Technology (Nanjing) Co., Ltd. romanized |
| 2025/09/26New drug · Class 1 | SIM0811注射液 · No verified English nameCXHL2501035 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Hainan Xian Sheng Pharma Co., Ltd. romanized |
| 2025/09/25Import · Class 1 | Budoprutug注射液 · No verified English nameJXSL2500183 | Climb Bio Inc.; Beijing Mabworks Biotech Company Limited |
| 2025/09/25Import · Class 2.4 | Fitusiran注射液 · No verified English nameJXHL2500298 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/09/25Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2503516 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2025/09/25Generic · Class 3 | 地塞米松磷酸钠滴眼液 · No verified English nameCYHS2503514 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized |
| 2025/09/25Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2503513 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/09/25Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2503512 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2025/09/25Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2503509 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2025/09/25Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500174 | Ou Pu Kang Shi Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1.1 | 天龙通络颗粒 · No verified English nameCXZL2500086 | Beijing Guo Ren Tang Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | N-3C01注射液 · No verified English nameCXSL2500832 | Hefei Xin Zhu Bio Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | 注射用HLX87 · No verified English nameCXSL2500831 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | HLX22单抗注射液 · No verified English nameCXSL2500830 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2500829 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/09/25New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSL2500828 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/25New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSL2500827 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2500826 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2500825 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2500824 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2025/09/25New drug · Class 1 | KH658眼用注射液 · No verified English nameCXSL2500823 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
44 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.