YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 460 drug applications between 23 September 2025 and 29 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 72 drug names.
2025/09/23 – 2025/09/29
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 111
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, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 93 |
| New drug | 88 |
| Import | 28 |
| Import re-registration | 14 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 264 |
| TCM | 106 |
| Therapeutic biologic | 83 |
| Prophylactic biologic | 4 |
| 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mometasone Furoate Cream | 4 | 2 | 16 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 3 | Ezetimibe and Atorvastatin Calcium Tablets(II) | 2 | 2 | 9 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 6 | Acetylcysteine Granules | 2 | 1 | 4 |
| 7 | Tacrolimus Ointment | 2 | 1 | 6 |
| 8 | Carboplatin Injection | 2 | 1 | 10 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
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
279 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 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 11 | 8 | 0 |
| 4 | AstraZeneca AB | 7 | 5 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Otsuka Pharmaceutical Co.,Ltd. | 6 | 1 | 0 |
| 7 | Shandong Qidu Pharmaceutical Co., Ltd. | 5 | 2 | 2 |
| 8 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Beijing Tong Ren Tang Pharmaceutical 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/29Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2500192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | 注射用MK-6070 · No verified English nameJXSL2500191 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | NNC6019-0001注射液 · No verified English nameJXSL2500190 | Novo Nordisk A/S; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2503587 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2503586 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/09/29Generic · Class 3 | Furosemide TabletsCYHS2503564 | Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2025/09/29Generic · Class 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2500175 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2025/09/29New drug · Class 3.1 | 泻白散颗粒 · No verified English nameCXZS2500043 | Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized; Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized |
| 2025/09/29New drug · Class 1.1 | 金防风袋泡茶 · No verified English nameCXZL2500090 | Jiangxi Shou Zheng Pharma Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSS2500102 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized; Beijing Hua Fang Tian Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/09/29New drug · Class 3.3 | GLR1044注射液 · No verified English nameCXSL2500849 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2500848 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500847 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | 注射用MRG003 · No verified English nameCXSL2500846 | Le Pu Bio Technology Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | SHR-4375注射液 · No verified English nameCXSL2500845 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500844 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2500843 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2025/09/29New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500842 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 2.2 | JMHT06 · No verified English nameCXHL2501056 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/09/29New drug · Class 2.2 | JMHT06 · No verified English nameCXHL2501055 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/09/29New drug · Class 1 | KR23343片 · No verified English nameCXHL2501054 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | KR23343片 · No verified English nameCXHL2501053 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2501052 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2501051 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | SGB-7342注射液 · No verified English nameCXHL2501050 | Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | MAX-10181片 · No verified English nameCXHL2501049 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/29New drug · Class 1 | MAX-10181片 · No verified English nameCXHL2501048 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/28Import · Class 3.1 | 注射用维布妥昔单抗 · No verified English nameJXSS2500129 | Takeda Pharma A/S; BSP Pharmaceuticals S.p.A.; Takeda (China) International Trading Co. Ltd |
| 2025/09/28Import · Class 1 | Ponsegromab注射液 · No verified English nameJXSL2500189 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/28Import · Class 1 | AZD5335 · No verified English nameJXSL2500188 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
103 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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