YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 513 drug applications between 25 December 2024 and 31 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 171, covering 124 drug names.
2024/12/25 – 2024/12/31
- New acceptances this week
- 513
- Drugs with new generic filings (by drug name, de-duplicated)
- 124
- Accepted this week, now under review
- 16
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
513filings, 171 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 171 |
| New drug | 108 |
| Import | 24 |
| Unspecified | 16 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 366 |
| TCM | 78 |
| Therapeutic biologic | 67 |
| Biologic | 1 |
| Prophylactic 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
124 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 7 | 4 | 20 |
| 2 | Lactulose Oral Solution | 6 | 3 | 34 |
| 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 4 | Cimetidine Injection | 3 | 3 | 5 |
| 5 | 甲氧氯普胺片 · No verified English name | 3 | 2 | 3 |
| 6 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 7 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 8 | Mirogabalin Besilate Tablets | 3 | 1 | 61 |
| 9 | Ibrutinib Capsules | 2 | 2 | 9 |
| 10 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
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
320 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 5 | 3 |
| 4 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 7 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 5 | 2 | 3 |
| 10 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 4 | 4 |
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
207 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/31Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2404639 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/12/31Generic · Class 3 | Tranexamic Acid and Sodium Chloride InjectionCYHS2404636 | Nanjing Hai Jing Pharma Co., Ltd. romanized; Hunan Jin Jian Pharma Co., Ltd. romanized |
| 2024/12/31Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2404631 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/31Generic · Class 3 | Raltitrexed for InjectionCYHS2404628 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2024/12/31Generic · Class 3 | Ferrous Succinate TabletsCYHS2404621 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2024/12/31New drug · Class 2.3 | 玉屏风袋泡茶 · No verified English nameCXZL2400100 | Guangzhou Bai Yun Shan Chen Li Ji Pharmaceutical Factory Co., Ltd. romanized |
| 2024/12/31New drug · Class 3.3 | 注射用奥马珠单抗 · No verified English nameCXSS2400143 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | 注射用GQ1005 · No verified English nameCXSL2400932 | Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400931 | Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2400930 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | BNT323 · No verified English nameCXSL2400929 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | ZMPB-NK006注射液 · No verified English nameCXSL2400928 | Hebei Mei Ou Sai Ao Jin Bio Technology Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | GO306重组溶瘤痘苗病毒注射液 · No verified English nameCXSL2400927 | Shanghai Jin Si Bio Technology Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400926 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | 人胎盘来源3D间充质干细胞注射液 · No verified English nameCXSL2400925 | Guo Jian Qing Ke Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | 注射用DM002 · No verified English nameCXSL2400924 | Si Dao Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2400923 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/31New drug · Class 2.4 | 赛沃替尼片 · No verified English nameCXHS2400134 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2024/12/31New drug · Class 2.4 | 赛沃替尼片 · No verified English nameCXHS2400133 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | SRSD216注射液 · No verified English nameCXHL2401496 | Jing Yin Pharma (Shanghai) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | IN10018片 · No verified English nameCXHL2401495 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | IN10018片 · No verified English nameCXHL2401494 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/31New drug · Class 1 | EP-0186片 · No verified English nameCXHL2401493 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/12/31New drug · Class 1 | EP-0186片 · No verified English nameCXHL2401492 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/12/31New drug · Class 1 | CVL237片 · No verified English nameCXHL2401491 | Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2024/12/30Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400258 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/12/30Import · Class 3.1 | 注射用sotatercept · No verified English nameJXSL2400257 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/12/30Import · Class 1 | Rilzabrutinib片 · No verified English nameJXHS2400121 | Genzyme Corporation; Sanofi S.r.l; Sanofi (China) Investment Co. Ltd. |
| 2024/12/30Generic · Class 3 | 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2404618 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/12/28Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2400256 | Seagen Inc.; Pfizer Investment CO. Ltd. |
177 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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